Construction and validation of a nursing care protocol in anesthesia 1

ABSTRACT Objective: To construct and validate a nursing care protocol in anesthesia. Method: methodological study of face and content validation, judging clarity, relevance, pertinence and comprehensiveness of a care protocol, elaborated from the integrative review of previous literature and based on the conceptual model of assistance perioperative nursing of Castellanos and Jouclas. The protocol was evaluated by five anesthesiologists and nurses from the surgical center. The results were analyzed through the content validity index. Results: among the 119 items assessed by experts, 11 (9.2%) instrument items presented content validity index of <80% and were changed. The items with disagreement were related to the selection and availability of materials and equipment, especially before anesthetic induction. The content validity index, obtained for the different items, proposed after the amendments mentioned, ranged from 80 to 100%, in the three periods of anesthesia, indicating the proper validity of the proposed content. Conclusion: the nursing care protocol in anesthesia was considered valid.


Introduction
Anesthesia allows the patient comfort during surgery, once the choice of the anesthesia category is based on the type, duration and approach required during the surgical procedure, associated with the clinical, mental and psychological conditions of the patient. Thus, the types of anesthesia are classified in general, regional and sedation (1) .
General anesthesia is necessary for procedures that require complete immobility and unconsciousness. It can be classified in three ways, defined as total venous, when only venous drugs are infused, such as propofol and etomidate, general inhalation, when administration of inhalational anesthetics like sevoflurane, desflurane.

The association between venous and inhalational
anesthetics is defined as general balanced anesthesia (1)(2) .
The general anesthesia is constituted by the reversible unconsciousness, immobility, analgesia and autonomic reflex block, whose components are hypnosis, analgesia, muscle relaxation and neurovegetative block (2) .
Hypnosis is characterized by suppression of consciousness, obtained through the use of inducing agents such as midazolam, propofol and etomidate.
Analgesia consists of the relief or absence of pain by the use of drugs such as opioids and anti-inflammatories.
Muscle relaxation occurs through the reduction of muscle tone, with the administration of relaxants such as succinylcholine, atracurium and rocuronium. The neuro-vegetative block occurs after adequate hypnosis and analgesia, with an attenuated response of the autonomic nervous system to the surgical stimulus, such as changes in heart rate, blood pressure and sweating (2) .
Regional anesthesia is selected for surgical procedures that address upper or lower limbs, abdomen or pelvic region. It can be performed by epidural nerve block, subarachnoid or plexus nerve block, with the administration of local anesthetics such as xylocaine, ropivacaine (1) . The association between general and regional anesthesia is defined as combined anesthesia.
Sedation is aimed at patient comfort in small or ambulatory surgical procedures, contributing to the reduction of anxiety, analgesia, decreased movement and maintenance of hemodynamic stability, mainly respiratory pattern and cardiovascular function (1,3) .
Adverse events related to health care and patient safety endangerment originate from human error, lack of teamwork and organizational failures (4) . Better communication and collaboration among professionals may reduce the risk of morbidity associated with the care of the surgical patient (5) . In this context, health care planning, consisting of physicians, nurses and anesthesiologists, is essential to reduce the risks of morbidity and mortality during the anesthetic-surgical procedure, thus promoting patient safety.
Studies indicate that adverse events related to anesthesia involve mainly the respiratory system, cardiovascular system, errors in the execution of regional blocks, equipment and device failures, adverse reactions to medications and lesions related to surgical decision (6)(7) .
The events of the respiratory system are caused by intubation difficulty, inadequate ventilation and oxygenation, aspiration, early extubation and airway obstruction (6)(7) . Concerning the cardiovascular system, adverse events are characterized by hemorrhages, bleeding, hydroelectrolytic imbalances and stroke. Equipment and device failures include the use of central and peripheral catheters, anesthesia equipment, burns and fires caused by the use of electric scalpel and thermal blanket (6)(7) .
Adverse drug reactions are due to incorrect dose administration and inadequate analgesia (6)(7) .
The main events in regional blocks are accidental dural puncture, high blockade, cardiac arrest, inadequate analgesia, trauma and catheter retention (6)(7) .
It should be noted, however, that the mortality risk associated with the anesthetic-surgical procedure has been reduced in the last 50 years due to initiatives for patient safety in anesthesia, which produced a higher quality of perioperative care (8)(9) .
These initiatives involved the advancement of training, certification and education of professionals for teamwork, development of medications and techniques, improvement of monitoring standards, greater quality in the risk assessment of the patient for surgery, along with the standardization behaviors through care protocols (8)(9) .
For the same purpose of care, the health care security, the American Committee on Quality and Health Care of the Institute of Medicine (IOM) presented, in 1999, the report To err is human: building a safer health system, proposing the governmental creation of a patient safety center that defined national goals for promoting safety and preventing errors related to health care (10) .
As a result of mortality and morbidity rates caused by surgical procedures, in 2002, The National Assembly of Lemos, CS, Poveda, VB, Peniche, ACG.
World Health Organization (WHO), released a resolution aimed at safety during anesthetic-surgical interventions, establishing standards of quality health services, including the implementation of safe anesthesia (11) .
The Safe Surgeries Saves Lives program was launched in 2008 by the WHO, with the development of a checklist that directed the assistance performed before the anesthetic induction periods, surgical incision and removal of the operating room (11)(12) .
The checklist, among several actions, provides for the anesthetic procedure, the checking of the functioning, availability of necessary equipment and materials, patient identification, verification of available tests, evaluation of risks associated with difficult airway via and blood loss (11)(12) .
It has been shown in studies that the application of the checklist was recognized by health professionals as an important instrument for the prevention of errors, increase of patient safety and assurance of greater assertiveness in inter-professional communication, which enables the previous assessment of the risks and behavior decisions for damage prevention. Thus, there was a reduction of postoperative complications among patients undergoing elective and emergency surgeries, with the reduction in the reporting of adverse health events (13)(14)(15)(16) .
Therefore, the care protocols, that is, the definition of a specific assistance/care situation, describing details about the operational actions and specifications about the mode of execution and professional execution, are instruments that can reduce the variability of conduct among the professionals involved in health care, to promote greater security for the patient and for the professional, to allow process and outcome indicators to be developed, to improve the quality of care and the rational use of resources (17) .
The behaviors recommended in the care protocols must be clear and accurate as to the expected results, to facilitate the use orientation and the understanding by the professionals (18) , besides being reviewed periodically, considering the local reality or application institution.
The construction of protocols must be based on scientific evidence, according to their levels of recommendation, based on the elements of quality, quantity and consistency of the reviewed studies (18) . The consistency element is equivalent to the degree of similar results in different study designs (18) .
In Brazil, according to article 4º of Law 12,842 of July 10 th , 2013, the execution of deep sedation, anesthetic blocks and general anesthesia are private activities of the physician (19) .
Regarding nursing, the world reality differs from the national one, with different levels of nursing autonomy in the anesthetic procedure. In the United States, there is a specialty of anesthesia in nursing, with certification (20) and defined care standards, which allow the planning and execution of all anesthetic procedures by the nurse (21) .
The American nurse who holds the title of specialist in anesthesia conducts nursing undergraduate course and specialization courses of two to three years to obtain professional certification, which must be revalidated every two years (20) . The professional can act in a freelance/self-employed, or in anesthesia groups, composed of nurses and/or physicians.
The American nurse responsibilities include preanesthetic evaluation, application of a consent form for the procedure, preparation of the anesthesia plan in any type of procedure, insertion of invasive devices for hemodynamic monitoring, administration of drugs for induction and maintenance of anesthesia, control of the airways and ventilatory pattern during surgery (21) .
In some European countries, such as France, Bulgaria and Switzerland, the anesthetist nurse performs certification courses from one to three years, and can perform anesthesia, monitoring and insertion of invasive devices, through defined protocols and under the direct or indirect supervision of medical anesthesiologists (22) .
In Brazil, unlike other countries, nurses do not have specific legislation that allows them to act in anesthesia care, with the same autonomy already seen in the countries mentioned.  Regarding anesthesia care, the surgical center nurse acts in the planning of materials and equipment required, according to the type of anesthesia, patient monitoring, intubation monitoring and ventilation control during anesthetic induction, helps in the control of signs endotracheal aspiration and transport of the patient in the anesthesia reversal phase (27) .
However, there is no anesthesia care standard for Brazilian nursing professionals, so each institution performs a different practice and care varies according to the interaction between the anesthesiologist and the nursing team.
The surgical center nurse encounters difficulties in the execution of the nursing process, due to the demand of the health institutions for the fulfillment of their assistance, administrative and managerial role.
The difficulty is aggravated by the fact that health institutions do not understand the importance of the nurse's role in assisting the surgical patient, leading to the misuse of assistance for managerial function (28) . Therefore, in order for nurses in a surgical center to perform their role of care in a relevant way, it is necessary to master the scientific knowledge and specificities of the changes generated by anesthesia and surgery, for adequate care planning and evidence of the significant role in the health team.
Thus, in this study the objective was to construct and validate a nursing care protocol in anesthesia.

Method
This is a methodological study of face validation and nursing care protocol content in anesthesia, based on results obtained in an earlier integrative review, evaluating the actions and care performed by the nursing team in the operating room during the anesthetic procedure (29) .
In order to construct the instrument, initially, the American and European anesthetist nurses standards (21,(30)(31) were observed, considering the Brazilian nursing professional practice law (32) , as a basis for structuring the proposed interventions together with the care suggested by the WHO Safe Surgery Checklist (11)(12) .
In accordance to the mentioned above, the theoretical framework that guided the construction of the care protocol was the conceptual model of The first version of the protocol was composed of interventions, involving the three assistance periods, evaluated by a group of five experts, regarding content validity criteria, clarity of items, relevance and completeness of content (33) . The main changes suggested were the improvement of the writing of the items, especially in the pre-induction period, and separation of materials and equipment into distinct items, so that the professional only indicates the devices related to the type of surgery that will be performed (33) .
In the induction period, the judges suggested revisions of the items regarding nursing notes and records, avoiding duplication of information, checking the patient's history and allergies directly in the medical chart, as well as reviewing the care of the Lemos, CS, Poveda, VB, Peniche, ACG.
anesthesiologist, such as assessment of ventilation and venous puncture (33) .
Before the suggestions, a second version of the care protocol was elaborated, with changes in the items regarding the appearance and form of presentation, followed by a new stage of face and content validation by five specialists.
In the second version of the care protocol, brief orientation of the objectives and form of completion of the instrument preceded the described periods.
Following, the nursing interventions for each period were described.
The total validity of an instrument is measured by face, content, construct and criterion-related validity (34) .
In this study, we sought to reach the first validation stages, that is, the structure and content of the protocol elaborated, through the evaluation by the judges of each item referring to its clarity, adequacy, relevance and completeness of content.
The validity of face represents how much a measure seems to be related to the specific content of the evaluated instrument, that is to say, if the content is understood by whom uses the instrument (34) . For the face evaluation, in this study, experts answered whether the graphic presentation, the orientation on the form of filling and readability, according to the sequence of presentation of the items, were adequate in the constructed protocol.

Content validity consists of representativeness
level of the concept that the instrument intends to measure and provides the items evaluation, according to clarity, relevance, pertinence and comprehensiveness of content (35) .
Clarity evaluates whether the construction of the items of the instrument, as the written form, allows adequate reading and promotes understanding of the content. The relevance indicates how the item represents the content that is being measured. Pertinence considers whether items of the instrument are suitable and specific to the assessment content. The completeness of content shows whether the instrument encompasses all items related you want to measure (35) .
Each item of the Protocol was scored from one to five, according to Likert type scale: (five) totally agree, In the scientific literature, it is recommended that the number of specialists selected varies between three and ten individuals (36)(37) , five is considered to be suitable for evaluation of the agreement (38) .
The selection of experts may vary according to the time of clinical experience of the participants, publications and specialization in the area of the research phenomenon, so, in this study, the experts were selected for their work as researchers/specialists in the field of anesthesiology and/or perioperative nursing.
At the end of the protocol evaluation by the expert group, the data were treated and analyzed by the CVI, which measures the proportion or percentage of agreement among experts on certain items of an instrument (39) .
In this study, the highest scores were adopted for the CVI calculation, that is, responses (four) agree and (five) totally agree for each item, divided by the total number of specialists, excluding values from one to three.
The acceptable agreement rate for this proportion was defined as 80% or higher (40) , with questions modification for those that did not reach this rate, according to the experts' suggestions, and a new round of evaluation.

Results
The care protocol was evaluated by five specialists, Regarding face validity, all experts stated that the graphical presentation, the guidelines for the filling form and the sequence structure of the items allowed an adequate reading and understanding of the care to be performed by the nurse during the anesthetic procedure.
Among the 119 items evaluated, only 11 (9.2%) items of the protocol presented CVI <80%, as presented in Table 1, and they were modified according to the experts' suggestions. There were no items excluded.
Most of the disagreements among the specialists occurred in the period before anesthetic induction, in which the evaluated items presented CVI ranging from 40 to 100% in the clarity criteria, from 80 to 100% in relevance, from 60 to 100% in pertinence and from 40 to 100% in completeness of content.  In the items on difficult airway, experts advised to better define the parameters of choice of materials such as the tracheostomy tube and the esophagus-tracheal tube (combitube) ( Table 1).
In the period of anesthetic induction, the evaluated items presented CVI from 80 to 100% in the criteria of clarity, relevance and pertinence and CVI from 60 to 100% in the completeness of content. The only item with disagreement was patient monitoring, for which it was suggested to explain the type of sensor used for temperature verification (Table 1).
In the period of anesthesia reversal, there was no change in the initially proposed items, which presented CVI from 80 to 100% in the criteria of clarity and completeness of content, 100% in the criteria of relevance and pertinence.
Following the evaluation of the experts' suggestions, the items were modified and submitted to a new round of evaluations and the CVI was recalculated, as presented in Table 2.   Rev. Latino-Am. Enfermagem 2017;25:e2952.

Introduction
Anesthesia is an essential procedure to perform the surgical procedure, which requires planning of the surgical team for quality and safety of care provided to the patient.

Objectives
Directing the nursing actions performed during general anesthesia (before anesthetic induction, during anesthetic induction and reversal of anesthesia), allowing the execution of the assistance in a planned and uniform manner in the various health services. Favor the joint work between the anesthesiologist and the nurse, for synchronism in the actions and better quality of the perioperative assistance.

Guidance
The items checked must be marked with: (X) for the item that was made; (NA) when the item does not apply to the procedure; (NE) for the item not executed (justify the reason)  Rev. Latino-Am. Enfermagem 2017;25:e2952.

Discussion
The results indicated a good agreement between the items evaluated by the specialists, considering that only 9.2% generated some type of disagreement and the divergences were mainly related to the criteria of choice, availability and selection of materials for the anesthetic procedure in the pre-induction period.
Most of the items of the induction period and all items of anesthesia reversal were considered valid by the specialists, affirming the importance of the care performed by the nurse in a surgical room.
The standardization of care offered by nursing during the anesthetic act contributes to the determination of the nursing role within this area, establishing a package of actions legally allowed in the country.
In Brazil, care and performance standards are clear for anesthesiologists (11)(12) . The physician should perform the pre-anesthetic visit to evaluate patient risk factors, such as blood loss greater than 500 ml during surgery, assessment of the anatomy of the mouth and difficulty in intubation, according to Mallampati's classification, risk of aspiration or airway allergies, alterations of tests, comorbidities and medications in use (11)(12) .
During anesthesia-surgical procedure, the presence of an anesthesiologist is required in the surgical room, the supply of supplemental oxygen to patients undergoing general anesthesia, monitoring of oxygen saturation by pulse oximetry and ventilation, circulation control and heart rate monitoring, measurement of blood pressure every five minutes, body temperature measurement and regular evaluation of anesthetic depth by clinical observation (11)(12) .
All these measures seek to prevent adverse events.
Thus, it is considered that the definition of care standards, with the identification of potential risks and necessary measures for the safety of interventions, combined with inter-professional work and good communication, can improve health care processes and outcomes (41)(42) .
In 1993, the American Society of Anesthesiologists (ASA), aiming at the adequate planning of anesthesia care and reduction of postoperative morbidity and mortality, considering the reality of each health service and the types of equipment available, developed a checklist, revised in 2008, which contained actions for execution before anesthetic induction (43) .
The checklist suggested items, some of which are also covered by this protocol, such as the anesthesia equipment operating test, soda lime check, auxiliary oxygen supply availability and bag-valve-mask device, vacuum for aspiration, availability of monitoring system and alarms, with emphasis on pulse oximetry and capnography, verification of the flow of gases and adequate pressure for ventilation in the anesthesia equipment, as well as the registration of any conference procedure (43) .
It is worth noting that WHO recommends minimum that, together, contribute for patient safety (44)(45)(46) .
All the professionals aligned with the scientific basis that guides the care to be performed, as well as the definition of limits and performance roles, contribute to a greater synchronism between the anesthetic procedure and the activities, and, therefore, Lemos, CS, Poveda, VB, Peniche, ACG. a greater probability of success interventions.
As a limitation, in this study, no pilot-application of the protocol was performed.

Conclusion
The nursing care protocol in anesthesia was validated with good agreement among specialists, and 90.8% of the items were considered adequate in the first round. Future work is needed to evaluate the practical application and feasibility of using the care protocol in different realities.