Nasotracheal Intubation With VL vs DL in Infants Trial (NasoVISI)

May 3, 2024 updated by: Children's Hospital of Philadelphia

Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial

Nasotracheal Intubation with Videolaryngoscopy versus Direct Laryngoscopy in Infants (NasoVISI) Trial is a prospective randomized multicenter study. The study will be conducted at 8 centers in the United States. It is expected that approximately 700 subjects enrolled to product 670 evaluable subjects.The randomization is 1:1 naso tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL). The primary objective is to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objectives of the study are to compare the nasotracheal intubation (NTI) first attempt success rate using VL vs. DL in infants 0-365 days of age presenting for cardiothoracic surgery and cardiac catheterizations.

Secondary Objectives include the number of attempts for successful intubation; Incidence of failed NTI (conversion to oral intubation); Incidence of failure to intubate with assigned device; Incidence of complications over all attempts including non-severe and severe complications; Incidence of 1st-attempt complications; Need for cricoid pressure or external laryngeal manipulation, need for adjunct- (Magill forceps), rescue of one technique of the other, Percent of glottic opening (POGO) score less than 100%, intubation sequence exceeding 60 seconds and interaction analysis of weight group (i.e. ≤ median weight & > median weight (kg)), and by clinicians' experience with cardiac anesthesiology (i.e. Permanent full time team members & rotating team members) on the association between treatment and outcomes

Study Design: this is a prospective, randomized, multi-center parallel group trial

Setting/Participants: This will be a multi-center study. The target population will be infants 0-365 days of age scheduled for elective cardiothoracic surgery or cardiac catheterization requiring general anesthesia with NTI.

Study Interventions and Measures: The study intervention will be a 1:1 randomization to perform tracheal intubation with the Storz C-Mac Video Videolaryngoscopy (VL) or the Standard Direct Laryngoscope (DL).

Main study outcome measures are as follows:

  • The first intubation attempt success rate with each device
  • The number of attempts for successful intubation with each device
  • Complications associated with intubation

Study Type

Interventional

Enrollment (Estimated)

1400

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

Study Contact Backup

  • Name: Paula Hu, MSPH
  • Phone Number: 2674262961
  • Email: hup@chop.edu

Study Locations

  • United States
    • Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203-6869
    • Texas
      • Austin, Texas, United States, 78723
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77030
    • Washington

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

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females age 0 -365 days
  • Scheduled for elective cardiothoracic surgery or cardiac catheterization procedures lasting longer than 30 minutes under general anesthesia where nasotracheal intubation will be performed by an anesthesiology clinician
  • Plan to use a neuromuscular blocking drug prior to intubation as standard of care
  • Parental/guardian permission (informed consent)

For clinician participants:

- Anesthesia attending, anesthesia fellows, anesthesia resident, Anesthesia Assistant (AA) or CRNA

Exclusion Criteria:

  • Less than 36 weeks gestation
  • Less than 2 kg
  • History of difficult intubation
  • History of abnormal airway
  • Predictive of difficult intubation upon physical examination
  • Preoperative endotracheal tube or tracheostomy
  • Emergency cases

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Videolaryngoscopy
Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope
Device: Nasotracheal intubation
Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy
Active Comparator: Direct Laryngoscopy
Nasotracheal Intubation performed with the standard clinical direct blades
Device: Nasotracheal intubation
Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VL first attempt success rate
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts for successful intubation
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours
Incidence of failed NTI (conversion to oral intubation)
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours
Incidence of failure to intubate with assigned device
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours
Incidence of complications over all attempts including non-severe and severe complications
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours
Incidence of 1st-attempt complications
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours
Incidence of additional techniques
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours
Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes
Time Frame: 24 hours
Direct observation of intubation in the OR and medical record review
24 hours

Collaborators and Investigators

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

Sponsor

Children's Hospital of Philadelphia

Collaborators

Baylor College of Medicine
Children's Hospital Colorado
Seattle Children's Hospital
Vanderbilt University Medical Center
Children's National Research Institute
Children's Medical Center Dallas
Dell Children's Medical Center of Central Texas

Investigators

  • Principal Investigator: Annery Garcia-Marcinikiewicz, MD, The Children Hospital of Philadelphia

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 (Actual)

June 6, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-019921

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

product manufactured in and exported from the U.S.

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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