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

NCT04089540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-03-16

No results posted yet for this study

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

Interventions

PROCEDURE

New intubation method

PROCEDURE

Conventional intubation method

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Nicholas Morris, MD · Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-01-31
Completion
2021-03-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089540 on ClinicalTrials.gov