New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates

NCT04089540 | Completed

• 1 other identifier: NOONA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation. Hypothesis

• The new intubation method is safe
• The new intubation method leads to a reduction in the number of intubation attempts
• The new intubation method leads to a reduction of desaturations and bradycardia during intubation
• In the long term, it could lead to a reduction in morbidity and mortality

Conditions

Intubation; Difficult or Failed; Preterm Infant; Term Infant

Outcome Measures

Primary Outcomes (1)

• Number of intubation attempts

  Changes in the number of intubation attempts

  During intubation process

Secondary Outcomes (6)

• Duration of intubation process in minutes

  During intubation process

• Number of desaturations

  During intubation process

• Total amount of time of desaturations

  During intubation process

• Cerebral tissue oxygenation

  5 minutes before intubation start till 10 minutes after successful intubation

• Morbidity

  up to 2 years

Study Arms (2)

Study group: New intubation method

EXPERIMENTAL

In the new intubation method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). Therefore an oxygen flow is already administered via the tube during the intubation process.

Procedure: New intubation method

Control group: Conventional intubation

OTHER

In the control group the respirator is connected to the tube and ventilation is started after the insertion of the tube into the trachea. Therefore there is no oxygen flow administered during the intubation process.

Procedure: Conventional intubation method

Interventions

New intubation method PROCEDURE

Study group: New intubation method

Conventional intubation method PROCEDURE

Control group: Conventional intubation

Eligibility Criteria

• Age: 1 Minute - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
• Fulfillment of indication for intubation

You may not qualify if:

• \- Malformation of the upper respiratory tract

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nicholas Morris, MD

  Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 13, 2019
• Study Start: October 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

AU (1)