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   Response -  Study Protocol
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Comparison of Post Extubation Stridor in Infants upto 3 months of age using Microcuff Endotracheal Tubes and Uncuffed Endotracheal Tubes - A Comparative Observational Study”

Aim: Comparison of post extubation stridor in infants intubated with microcuff endotracheal tubes and uncuffed endotracheal tubes.

Introduction: Cuffed endotracheal tubes (ETT) are increasingly used in infants and children. There are several retrospective studies on the safety of microcuff ETT tubes in pediatric population, however, there is limited evidence in literature regarding its use and safety in infants upto 3 months of age undergoing general anesthesia.

Objectives:

Primary Objective:

·      To compare the proportion of infants developing post extubation stridor

 after use of microcuff and uncuffed ETT.

Secondary Objective:

·      To compare the proportion of infants developing postoperative respiratory adverse events RAE (desaturation, laryngospasm, bronchospasm, coughing, soft tissue airway obstruction) after use of microcuff and uncuffed ETT.

·      Number of endotracheal tube exchanges required while securing the airway with microcuff ETTs and uncuffed ETTs.

Primary Outcome:

·      Number of children developing stridor after extubation in both the groups.

Secondary Outcomes:

·      Number of children developing postoperative respiratory adverse events RAE (desaturation, laryngospasm, bronchospasm, coughing, soft tissue airway obstruction) after extubation in both the groups

·      Number of endotracheal tube exchanges required to ensure appropriate size ETT in both the groups.

Materials and Methods:

Study Design:

This comparative observational study will be conducted in the Department of Anesthesia, Chacha Nehru Bal Chikitsalaya, Delhi after taking parental written informed consent. This study will also be registered with Clinical Trial Registry of India.

Study period: April 2024 to December 2024

Inclusion Criteria:

·      Term neonates and preterms with post conceptional age more than 37 weeks at the time of surgery

·      Infants upto three months of age

·      Patients requiring endotracheal intubation for general anaesthesia, posted for both elective and emergency procedures

·      Surgical procedures being done in supine position

Exclusion Criteria:

·      Children requiring post-operative ventilation in ICU

·      Syndromic child

·      Children with airway anomalies including Tracheo-esophageal fistula

Methodology:

The patients will be randomized into two groups based on the type of endotracheal tube that will be used for securing the airway i.e. uncuffed ETT (Gp U) and microcuff ETT (Gp M); where, Gp M will include patients intubated with size 3.0 microcuff ETT and Gp U will include patients intubated with the appropriate size ETT decided by the anaesthesiologist performing laryngoscopy on visual estimation of glottic opening.

Direct laryngoscopy will be done and oral endotracheal intubation will be performed by paediatric anaesthesiologist as per the group assigned. Leak will be assessed by auscultation, in both the groups. Appropriate tube size and adequate ventilation will be ascertained. The number of tube exchanges required to ascertain the appropriate size tube, duration of surgery, occurrence of stridor, laryngospasm, bronchospasm, desaturation (SpO₂<95%), use of CPAP (continuous positive airway pressure), steroids, adrenaline nebulization to relieve stridor, reintubations required, if any and vital parameters will be recorded.

Statistical Methods:

Statistical testing will be conducted with freely available online statistical program. Continuous variables will be presented as mean±SD or median (IQR) for non-normally distributed data. Categorical variables will be expressed as frequencies and percentages. The comparison of normally distributed continuous variables between the groups will be performed using Student’s t test. Nominal categorical data between the groups will be compared using Chi-squared test or Fisher’s exact test as appropriate. Non-normal distribution continuous variables will be compared using Mann Whitney U test. For all statistical tests, a p value less than 0.05 will be taken to indicate a significant difference.