Nasotracheal Intubation With VL vs DL in Infants Trial (NasoVISI)
Primary Purpose
Intubation Complication, Intubation; Difficult or Failed, Hypoxia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasotracheal intubation
Sponsored by
About this trial
This is an interventional treatment trial for Intubation Complication focused on measuring Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Intubation complications, Intubation technical difficulties, Randomization, Multi-center
Eligibility 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
Sites / Locations
- Children's Hospital ColoradoRecruiting
- Children's National Medical CenterRecruiting
- The Children's Hospital of Philadelphia
- Vanderbilt University Medical CenterRecruiting
- University of Texas at Austin Dell Children's Medical CenterRecruiting
- Children's Medical Center DallasRecruiting
- Texas Children's HospitalRecruiting
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Videolaryngoscopy
Direct Laryngoscopy
Arm Description
Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope
Nasotracheal Intubation performed with the standard clinical direct blades
Outcomes
Primary Outcome Measures
VL first attempt success rate
Direct observation of intubation in the OR and medical record review
Secondary Outcome Measures
Number of attempts for successful intubation
Direct observation of intubation in the OR and medical record review
Incidence of failed NTI (conversion to oral intubation)
Direct observation of intubation in the OR and medical record review
Incidence of failure to intubate with assigned device
Direct observation of intubation in the OR and medical record review
Incidence of complications over all attempts including non-severe and severe complications
Direct observation of intubation in the OR and medical record review
Incidence of 1st-attempt complications
Direct observation of intubation in the OR and medical record review
Incidence of additional techniques
Direct observation of intubation in the OR and medical record review
Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes
Direct observation of intubation in the OR and medical record review
Full Information
NCT ID
NCT05433155
First Posted
June 21, 2022
Last Updated
July 19, 2023
Sponsor
Children's Hospital of Philadelphia
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, Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05433155
Brief Title
Nasotracheal Intubation With VL vs DL in Infants Trial
Acronym
NasoVISI
Official Title
Nasotracheal Intubation With Videolaryngoscopy Versus Direct Laryngoscopy in Infants (NasoVISI) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
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, Vanderbilt University Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Complication, Intubation; Difficult or Failed, Hypoxia, Hypoxemia, Anesthesia Intubation Complication, Pediatric HD
Keywords
Laryngoscope, Video Laryngoscope, Direct Laryngoscope, Nasotracheal Intubation, First attempt success, Intubation complications, Intubation technical difficulties, Randomization, Multi-center
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, multi-center parallel group trial
Masking
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.
Allocation
Randomized
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Videolaryngoscopy
Arm Type
Active Comparator
Arm Description
Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope
Arm Title
Direct Laryngoscopy
Arm Type
Active Comparator
Arm Description
Nasotracheal Intubation performed with the standard clinical direct blades
Intervention Type
Device
Intervention Name(s)
Nasotracheal intubation
Intervention Description
Nontracheal intubation using clinical standard videolaryngoscopy or direct laryngoscopy
Primary Outcome Measure Information:
Title
VL first attempt success rate
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of attempts for successful intubation
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Title
Incidence of failed NTI (conversion to oral intubation)
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Title
Incidence of failure to intubate with assigned device
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Title
Incidence of complications over all attempts including non-severe and severe complications
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Title
Incidence of 1st-attempt complications
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Title
Incidence of additional techniques
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
Title
Interaction analysis of weight group and by clinicians' experience with cardiac anesthesiology on the association between treatment and outcomes
Description
Direct observation of intubation in the OR and medical record review
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Nicolson, MD
Phone
2155901874
Email
nicolson@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Hu, MSPH
Phone
2674262961
Email
hup@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annery Garcia-Marcinikiewicz, MD
Organizational Affiliation
The Children Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Twite
Email
Mark.Twite@childrenscolorado.org
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Deutsch
Phone
202-420-1187
Email
ndeutsch@childrensnational.org
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-6869
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kuntz
Email
Michael.Kuntz@vumc.org
Facility Name
University of Texas at Austin Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Gottlieb
Email
erin.gottlieb@austin.utexas.edu
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Zabala
Email
LUIS.ZABALA@childrens.com
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Vener
Email
dfvener@texaschildrens.org
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Latham
Email
gregory.latham@seattlechildrens.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Nasotracheal Intubation With VL vs DL in Infants Trial
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