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

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ClinicalTrials.gov Identifier: NCT05433155
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : December 6, 2022
Sponsor:
Collaborators:
Children's Hospital Colorado
Seattle Children's Hospital
Baylor College of Medicine
Children's Medical Center Dallas
Dell Children's Medical Center of Central Texas
Children's National Research Institute
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intubation Complication Intubation; Difficult or Failed Hypoxia Hypoxemia Anesthesia Intubation Complication Pediatric HD Device: Nasotracheal intubation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, multi-center parallel group trial
Masking: Single (Participant)
Masking Description: Blinding of the device for clinicians and study staff is not feasible in this study. Participants will be blinded. The statisticians will be blinded at the time of generating the randomization schedule and remain blinded at the time of analysis.
Primary Purpose: Treatment
Official Title: Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial
Actual Study Start Date : June 6, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. VL first attempt success rate [ Time Frame: 24 hours ]
    Direct observation of intubation in the OR and medical record review


Secondary Outcome Measures :
  1. Number of attempts for successful intubation [ Time Frame: 24 hours ]
    Direct observation of intubation in the OR and medical record review

  2. Incidence of failed NTI (conversion to oral intubation) [ Time Frame: 24 hours ]
    Direct observation of intubation in the OR and medical record review

  3. Incidence of failure to intubate with assigned device [ Time Frame: 24 hours ]
    Direct observation of intubation in the OR and medical record review

  4. 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

  5. Incidence of 1st-attempt complications [ Time Frame: 24 hours ]
    Direct observation of intubation in the OR and medical record review

  6. Incidence of additional techniques [ Time Frame: 24 hours ]
    Direct observation of intubation in the OR and medical record review

  7. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05433155


Contacts
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Contact: Susan Nicolson, MD 2155901874 nicolson@chop.edu
Contact: Paula Hu, MSPH 2674262961 hup@chop.edu

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Mark Twite       Mark.Twite@childrenscolorado.org   
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Nina Deutsch    202-420-1187    ndeutsch@childrensnational.org   
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Laura Downey       laura.ansley.downey@emory.edu   
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Susan Nicolson, MD    215-590-1874    nicolson@chop.edu   
United States, Texas
Dell Children's Medical Center Recruiting
Austin, Texas, United States, 78723
Contact: Erin Gottlieb       erin.gottlieb@austin.utexas.edu   
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Luis Zabala       LUIS.ZABALA@childrens.com   
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: David Vener       dfvener@texaschildrens.org   
United States, Washington
Seattle Children's Hospital Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Gregory Latham       gregory.latham@seattlechildrens.org   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Hospital Colorado
Seattle Children's Hospital
Baylor College of Medicine
Children's Medical Center Dallas
Dell Children's Medical Center of Central Texas
Children's National Research Institute
Children's Healthcare of Atlanta
Investigators
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Principal Investigator: Annery Garcia-Marcinikiewicz, MD The Children Hospital of Philadelphia
More Information
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Publications:

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT05433155    
Other Study ID Numbers: 22-019921
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Children's Hospital of Philadelphia:
Laryngoscope
Video Laryngoscope
Direct Laryngoscope
Nasotracheal Intubation
First attempt success
 Intubation complications
Intubation technical difficulties
Randomization
Multi-center
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory