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

NCT ID: NCT04089540

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group: New intubation method

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.

Group Type: EXPERIMENTAL

New intubation method

Intervention Type: PROCEDURE

Control group: Conventional intubation

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.

Group Type: OTHER

Conventional intubation method

Intervention Type: PROCEDURE

Interventions

New intubation method

Intervention Type: PROCEDURE

Conventional intubation method

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Malformation of the upper respiratory tract

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Morris, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Graz, , Austria

Countries

Austria

Other Identifiers

NOONA

Identifier Type: -

Identifier Source: org_study_id