Videolaryngoscopy for Intubation in Neonates: an Evaluation– a randomized controlled study (The Vine study)

Not Applicable

Completed

• Conditions: Intubation of the neonatal trachea; Reproductive Health and Childbirth - Complications of newborn; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12613000159752
• Lead Sponsor: Prof Peter Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Infants in the delivery room, operating theatre or in the Newborn Intensive and Special Care (NISC) unit of The Royal Women’s Hospital, Melbourne who require oral endotracheal intubation will be eligible for entry to this study.

Exclusion Criteria

Infants will be not be recruited if they are in extremis requiring immediate intubation by a senior experienced operator who will use his/her own preferred method.
Infants who will be intubated nasally will not be included as this technique is generally not taught to registrars.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of successful intubation on first attempt. An attempted intubation will be defined as the insertion of the laryngoscope into the infant’s mouth.[The duration of the intubation attempt<br>]

Secondary Outcome Measures

Name	Time	Method
Time taken for the intubation attempt[The time taken is defined by the time difference between when the laryngoscope is inserted and subsequently removed from the patient’s mouth. ];The lowest oxygen saturation and heart rate during the procedure. The oxygen saturation will be read from the attached pulsoximeter and the heart rate read either from the pulseoximeter or the infants electrocardiograph recording if attached.[The duration of the intubation attempt];The rate of endotracheal tube adjustment following chest x-ray evaluation[6 hours following the intubation];Qualitative data will be obtained from the registrars about their experience of the intubation attempt[Recorded as soon as possible after the intubation attempt]