1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drshaileshpgi@gmail.com].
   


6. For how long will this data be available start date provided 01-05-2022 and end date provided 01-05-2026?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

Neonatal intubation is a common procedure done in neonates who require respiratory support for various reasons. Studies suggest that nearly half of intubation attempts are unsuccessful.¹ Failed intubation attempts have been associated with intraventricular hemorrhage, hypoxia, and neurodevelopmental delay in infants.² An Australian study reported that 62% of total first intubation attempts were successful, but the success rate was only 24% among the most inexperienced trainees¹.

  Various factors may be responsible for failed intubation attempts. The endotracheal tubes (ETTs) used may be too flexible. This may have both pros and cons. It may be less traumatic, however, the flexibility of the ET tube may make the intubation procedure difficult.  Many operators insert a stylet (a sterile, coated wire/metal, which can be curved) into the lumen to stiffen the ETT. Stylet use during neonatal intubation is common. There are various types of stylet available which again has advantages and disadvantages.

    In a survey conducted in the US, 57% reported using a stylet ‘every time’ or ‘almost every time’ they intubated. 71% of respondents believed that stylets were safe³. It is not known whether their use increases the rate of intubation success.⁴ Omar et al concluded from their study that using an endotracheal stylet did not significantly improve the success rate of pediatric trainees at neonatal orotracheal intubation.⁵ Three hundred two intubations were performed in 232 infants (residents performed 75%, fellows 25%). Intubation was successful in 57% of the stylet group and 53% of the no stylet group (P = .47) with no differences in the duration of attempts or the rate of upper airway trauma between the 2 groups. Hence, there is no consensus regarding their use. Reported complications from stylet use included tube dislodgement during stylet removal (32%), airway injury with bleeding (9%), and tracheal perforation (2%).³

Current guidelines state that intubation may be performed by using an ETT with or without a stylet. A recent Cochrane review suggests that the use of a stylet during neonatal orotracheal intubation does not significantly improve the success rate among pediatric trainees however there were various limitations of the studies included in this review.⁶

 In this study we want to document the usefulness of  stylet  and want to analyse that it has any impact on the success rate of intubation and want to compare it with Plain ET tube intubation  without stylet.

Methodology:

This randomized controlled trial will be conducted in neonatal surgical ICU, PGIMER Chandigarh in the period between March 2022 and  April 2023.  Randomization will be done by computer generated random table. The consent for the emergency procedure like intubation is routinely taken  at the time of admission. Similarly the informed consent  for the enrolment in the study will also be taken at the time of admission from all the patients’ attendants.

Inclusion criterion-

All neonates in Neonatal surgical ICU requiring intubation, irrespective of gestational age

Exclusion criterion-

Postoperative Tracheoesophageal fistula

Craniofacial or airway anomalies 

Tracheal and laryngeal anomalies

Subglottic stenosis

Syndromic Child

Primary outcome-

·       Rate of the successful first attempt at orotracheal intubation

Secondary outcomes-

·       Duration of the intubation in seconds

·       Number of intubation attempts

·       Patient instability during the procedure, as measured by:

·       Heart rate (HR) < 100 during the procedure; and

·       Desaturation to < 70% (with 100% showing full oxygen saturation).

·       Local trauma to the airway or surrounding soft tissue diagnosed by the presence of blood‐stained endotracheal aspirates or oral sections over the 24 hours after the attempt.

·       Evidence of airway damage, for example, post‐extubation stridor, subglottic stenosis, or vocal cord paralysis

·       The neonates will be assigned to either of the groups based on the sequentially numbered sealed opaque envelopes containing computer-generated treatment groups no., which will be stored in a cupboard within the NSICU. Considering the nature of the study, It won’t be possible to mask the intervention.

Intubation will be performed by using sterile, single-use, uniform internal diameter (ID), plastic Endotracheal tubes (Portex) of an appropriate ID based on the infant’s actual or estimated birth weight (2.5 mm ID for infants,1 kg; 3.0 mm ID for infants 1– 2.5 kg; 3.5 mm ID for infants .2.5 kg). All the enrolled neonates will be assigned to the following groups:

Group A: Intubation without a stylet

Group B: Intubation with a stylet

For infants randomized to the stylet group ( Group B), a disposable intubation stylet will be inserted into the ETT lumen. The manufacturers recommend this stylet for use with ETTs of 2.5 to 4.5 mm ID. The stylet will be so positioned so that the tip did not protrude beyond the ETT. If unsuccessful in group A, operators will be free to use stylets in further attempts which will also be recorded. The level of experience of the operator will be recorded. The operator’s preference (stylet, no stylet, or no preference) will also be recorded. An attempt to intubate will be defined as the introduction of the ETT into the infant’s mouth after laryngoscopy. Correct ETT placement will be confirmed clinically as well as a chest radiograph to confirm ETT position. Time to intubate will be taken as time from insertion until removal of the laryngoscope. It will be measured by the nursing officer or the assistant present to assist the procedure using a digital stopwatch. Baseline readings for HR and pulse oxygen saturation (spo2) will be recorded from a pulse oximeter and the lowest HR and spo2 during the procedure documented.