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

Preterm Infant Clinical Trial

— NOONA  

Official title:

New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089540
• Other study ID #: NOONA
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2021

Study information

• Verified date: March 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Intubation; Difficult or Failed
• Preterm Infant
• Term Infant

Intervention

Procedure:
• New intubation method

• Conventional intubation method

Locations

Country	Name	City	State
Austria	Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intubation attempts	Changes in the number of intubation attempts	During intubation process
Secondary	Duration of intubation process in minutes	Changes in duration	During intubation process
Secondary	Number of desaturations	The number of desaturations below 80% SpO2; The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.	During intubation process
Secondary	Total amount of time of desaturations	The total amount of time in seconds a patient spends below 80% SpO2.; The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.	During intubation process
Secondary	Cerebral tissue oxygenation	Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation	5 minutes before intubation start till 10 minutes after successful intubation
Secondary	Morbidity	Changes in morbidity	up to 2 years
Secondary	Mortality	Changes in mortality	up to 2 years