Efficacy of preoperative anesthetic safety checklist for simulated emergency caesarean section in multipurpose operation theatre setup in a developing country: An observational study

Strength and limitations of the study

Introduction

“Primum non Nocera” or “non-maleficence,” i.e., “Do no harm” is the core and non-negotiable ideal of the sacred Hippocratic oath.¹ The science and art of medicine have been founded, advanced, and are still evolving to enhance patient safety.^1,2 Patient safety involves the prevention of errors in healthcare administration, which could result in temporary or long-standing adverse outcomes.^1,3

Specialties such as anaesthesia are at heightened risk of lapses in patient safety protocols.⁴ Operation theatres, especially in developing countries, are shared by multiple departments. The preparation of operations in such settings is performed by postgraduates in anaesthesia departments, along with operation technologists. Dysfunction, delayed judgement, or oversight of even minute aspects by even a single individual of the team can expose the patient to an incompressible risk, and reports are replete with incidences of “wholly preventable surgical adverse events” or “never events” including morality, permanent, or temporary injuries.⁵

Identifying the pressing need for measures to decrease the risk of “never events” to surgical patients, the World Health Organization (WHO) has proposed guidelines and designed a WHO surgical checklist to reduce the rate of major surgical complications.^1,2,5,6 “Checklists” are defined as “organisational aids” in efficient implementation of complex multistep tasks.⁷ Checklist enables breakdown of a complex procedure into simple task steps and provides rules/ prompts on the key aspects of each steps including what is required, from where or whom it should be procured and leads on how a particular task/procedure needs to be performed stepwise.^7–9 The Anaesthesia Patient Safety Foundation (APSF) states that anaesthesia-related incidents are often caused by “temporary and atypical lapses in the vigilance of otherwise competent anaesthetists” and the adoption of checklists for critical stages of anaesthesia might drastically reduce the incidence of such lapses.¹ The use of checklists in anaesthesia aids beginners to perform practical anaesthesia procedures efficiently and safely and to feel effectively supported by reducing errors due to oversight, stress, fatigue or monotony.⁷

This study aimed to determine the efficacy of a validated anaesthesia safety checklist in reducing the frequency of missed steps in the pre-anaesthesia setup of patients undergoing simulated emergency caesarean sections. This study also aimed to measure the comfort level of anaesthesia residents using a checklist.

Materials and methods

The present study is a single-center prospective cross-sectional study carried out in the Department of Anaesthesiology at a tertiary care hospital in a developing country between 2022-2023, after obtaining approval from the Institutional Ethics Committee (560/2022) on 1^st April 2023 and registering the study with CTRI (057174). Based on the average incidence of 11.5% missed steps (Tscholl et al.),¹⁰ the estimated sample size for assessing the efficacy of checklist use on pre-preparation was found to be 49.

Consent: written informed consent was taken from the participants prior to commencement of study.

Results

The efficacy of the validated checklist was assessed among 25 randomly postgraduates selected. The postgraduates were prompted to prepare the OT twice, randomly assigned once with the checklist and once without the checklist, thus obtaining a total of 50 responses. There were six first-year, nine second-year, and ten third-year postgraduates ( Figure 1).

Figure 1. Pie Chart showing the number of participants as per year of residency.

It was observed that of cumulative 550 mandatory attributes, 87 was missed without checklist.

When considering desirable attributes, 108 “desirable” attributes out of 150 were missed by postgraduates while setting up OT in the absence of checklists.

In comparison, 12 “mandatory” and 24 “desirable” attributes were missed while preparing OT in the presence of the curated anaesthesia safety checklist; the difference was statistically significant with a p-value of 0.036.

Table 2 summarizes the performance of the postgraduates in fulfilling the “Mandatory” technical/infrastructural attributes of the pre-anaesthesia setup for a class 1 emergency caesarean section in the presence and absence of a checklist.

This shows that providing the validated anaesthesia safety checklist on the pre-anaesthesia setup resulted in significant improvements in compliance to ensure the presence of a functioning operation table, the availability of a difficult airway cart, the presence of nasopharyngeal and oropharyngeal airways, and the availability of blood forms inside the OT.

Table 3 summarizes the performance of the postgraduates in ensuring the presence of “mandatory” medications required while performing a class 1 emergency caesarean section, in the presence and absence of a checklist.

This shows that checklist-aided OT preparation resulted in significant improvements in compliance to ensure the presence of critical drugs, such as tranexamic acid, ondansetron, succinylcholine, and non-depolarizing muscle relaxants, while pre-anaesthesia setup of OT for a class 1 emergency caesarean section.

Table 4 summarizes the efficacy of the checklist in enhancing the performance of postgraduates in ensuring the presence of “Desirable to have” attributes.

The checklist resulted in significant improvements in compliance to ensure the availability of body warmer, fluid warmer, syringe infusion pumps, and noradrenaline ampules while preparing the OT.

Furthermore, all postgraduates who participated in the study reported that the checklist was easy to comprehend and comfortable to use.

Discussion

Management of obstetric emergencies, including suspected uterine rupture, eclampsia, preeclampsia, and placental abruption, is a life-threatening challenge requiring emergency caesarean sections in a high-risk setting, calling for a multidisciplinary approach.^11,12 The anaesthetic management of such cases remains a challenge and greatly affects maternal and neonatal outcomes.¹² The goals of resuscitation in obstetric emergencies remain similar to any other medical emergency, with the distinction of focusing on resuscitation and safety or ensuring minimum adversities to two lives.¹³ Anaesthesia postgraduates are beginners in this field and may find it difficult to meet the requirements of a pre-anaesthesia setup for a class 1 emergency caesarean section.¹² The criterion-based step-wise approach in prompting to ensure a well-quipped OT in a simulated scenario aids in the clear definition of roles and the essence of a multidisciplinary approach in handling real emergencies.^8,9 Checklists act as cognitive aids, aiding the preparation and evaluation of postgraduates in handling emergencies in both simulated and real-life scenarios.^1–9 The present study focused on designing an anaesthesia safety checklist on a pre-anaesthesia setup for a class-1 emergency caesarean section using the Delphi method. The checklist included technical requirements and drugs under “Mandatory” and “Desirable” categories with respect to ensuring their availability in the OT. The designed checklist was found to be reliable (0.889), according to the Kuder-Richardson formula. This designed and validated checklist was evaluated for efficacy among anaesthesia postgraduates. The study showed significant improvements in compliance to ensure the presence of a functioning operation table, a difficult airway cart, nasopharyngeal and oropharyngeal airways, blood forms, and critical drugs. Evaluation of the “desirable” attributes also reported significant improvements in compliance to ensuring the availability of body warmer, fluid warmer, syringe infusion pumps, and noradrenaline ampules during OT preparation. The availability of propofol ampules, ketamine vials, succinylcholine, routinely used non-depolarizing muscle relaxants, and the difficult airway cart was consistently high in the checklist group. Cumulatively, a statistically significant improvement was recorded in both “mandatory” and “desirable” attributes of postgraduates when using the checklist.

Optimal management of obstetric emergencies remains a core area of focus to address preventable maternal and neonatal mortality and morbidity, especially in low resource settings.¹⁴ Simulated learning and replication of emergencies through virtual reality along with assisted cognitive aides/checklists ensures greater preparedness among medical professionals to handle such emergencies.¹⁵ Identification of the benefits of such simulated criterion based learning and evaluation, resulted in the constitution of the Obstetric Anaesthesia SAFE courses and the Vital Anaesthesia Simulation Training (VAST) which focus on “equipping anaesthesia providers with the essential skills and knowledge to deliver safe care to their patients, even in low-resource settings” and inter-disciplinary approaches in teaching and reaffirming “peri-operative practices and non-technical skills,” respectively.^16–18 Recent studies have explored the efficacy of pre-validated and newly designed checklists for emergency caesarean sections, as well as other medical emergencies. Abrams et al. discussed the value of multi-professional training in obstetric anaesthesia by emphasizing how it can enhance collaboration, communication, and the use of cognitive supports.¹⁹ The study reported enhanced maternal and newborn outcomes resulting from simulation-based multi-professional training in crisis resource management principles.¹⁹ Barbara et al. performed a randomized control trial and reported that anaesthesiology residents who received concentrated instruction on a simulator performed better than those who did not during the simulated scenario.²⁰ According to the study, simulation-based training can be an effective method for imparting rare but essential/crucial anaesthetic abilities, which corresponds to the findings in our study where the performance by the postgraduates was enhanced while using the checklist.²⁰

Efficacy of checklist aided simulated learning in evaluation of clinical skills, debriefing, practice, and reassessment is also being explored. Another study by Gaba et al reported the use of checklist for simulated anaesthesia crises for evaluation of clinical skills, the checklist included certain “essential” items that, if missed, resulted in a failing score even if all other aspects of the simulated anaesthetic were performed perfectly, the study reported higher failed attempts in absence of checklist.²¹ This translates to the fact that the checklist serves as an aid in ensuring better compliance while teaching in simulated scenarios and ensuring better preparedness, increased confidence, and improved inter-professional collaboration/teamwork and communication in handling real-life medical crisis.²¹ Technical skills in obstetric anaesthesia, such as airway care, blood loss prediction, and epidural administration, can be taught more effectively using simulation through “exposure, practice, and reflection”.^16–22 Without putting patients in danger, in-situ simulation in the labor and delivery unit can assist in locating latent mistakes and system-level issues.²³ With scoring systems designed to assess resident performance during simulated scenarios, simulation can be utilized to identify deficits, improve skills, and facilitate preparedness in handling real crisis.²¹

Conclusions

Cognitive aids in simulated learning scenarios ensure fewer oversights in missing critical aspects of emergency medical management, and facilitate better preparedness in handling real-life scenarios. The development of mandatory institutional checklists for postgraduate medical education and real-life practice facilitates better patient outcomes as well as improved technical and non-technical skill sets in clinicians pertaining to teamwork, preparedness, and confidence. Collaboration between healthcare organizations, professional societies, and policymakers can aid in developing standardized checklists for emergency caesarean sections, as well as other medical emergencies, and aid in streamlining the best practices in implementation strategies across institutions.

Ethics and consent

The study protocol was reviewed and approved by the Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital, Manipal (DHR Registration No. EC/NEW/INST/2024/KA/0509).

The approval date was 01/04/2023, valid for one year from the date of approval. The protocol number assigned to this study IEC: 560/2022. Individual informed consent specific to this study was taken and all participants gave consent for the use of their data for research purposes with strict adherence to anonymity, and in accordance with all relevant regulations and ethical standards, adhering to the Declaration of Helsinki.