Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table (IntTab)

June 19, 2024 updated by: Daniele Trevisanuto, University Hospital Padova

Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table: a Randomized Crossover Manikin Study

The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated.

This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures.

Objectives: To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time, and participants' opinions on the procedures were investigated.

Methods: This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Level III NICU and PICU consultants, and pediatric residents

Exclusion Criteria:

  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Device: Direct laryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Active Comparator: Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Device: Videolaryngoscope and table at xiphoid level
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Active Comparator: Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Device: Direct laryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Experimental: Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level
Device: Videolaryngoscope and table at umbilical level
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnitide of applied forces (Newton)
Time Frame: 3 minutes
Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation
3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving the intubation success at the first attempt
Time Frame: 30 seconds
The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer
30 seconds
Total time of intubation
Time Frame: 3 minutes
Time of device positioning will be calculated as the sum of the time of device positioning in all attempts, as the procedure will be repeated in case of incorrect positioning
3 minutes
Participant's opinions about the procedure
Time Frame: 12 hours
Participants will report: their preference about table height and device; perceived difficulty using a Likert scale (1= not difficult, 5=very difficult)
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOUNIPD5(2024)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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