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Device

Videolaryngoscope vs Regular Laryngoscope for Infant Intubation (NasoVISI Trial)

N/A
Recruiting
Led By Annery Garcia-Marcinikiewicz, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females age 0 -365 days
Plan to use a neuromuscular blocking drug prior to intubation as standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

NasoVISI Trial Summary

This trial is studying whether using a videolaryngoscope is better than using a regular laryngoscope for intubating infants for cardiothoracic surgery or cardiac catheterization.

Who is the study for?
This trial is for infants aged 0-365 days who need general anesthesia for elective cardiothoracic surgery or cardiac catheterization. They must be scheduled to receive a muscle relaxant before intubation and have no history of difficult intubation, abnormal airway, preoperative breathing tubes, or tracheostomy. Infants born before 36 weeks gestation or weighing less than 2 kg are excluded.Check my eligibility
What is being tested?
The NasoVISI Trial compares two methods of nasotracheal intubation in infants: Videolaryngoscopy (VL) using the Storz C-Mac Video system versus Standard Direct Laryngoscopy (DL). The study aims to determine which method has a higher first attempt success rate during surgeries and procedures lasting over 30 minutes.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of intubation, bleeding from the nose due to tube insertion, sore throat after removal, and more rarely damage to teeth or soft tissues in the mouth and throat.

NasoVISI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a newborn, less than 1 year old.
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I will be given a muscle relaxant before being put on a breathing tube.
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I am scheduled for heart or chest surgery under general anesthesia that will last more than 30 minutes.

NasoVISI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
VL first attempt success rate
Secondary outcome measures
Incidence of 1st-attempt complications
Incidence of additional techniques
Incidence of complications over all attempts including non-severe and severe complications
+4 more

NasoVISI Trial Design

2Treatment groups
Active Control
Group I: VideolaryngoscopyActive Control1 Intervention
Nasotracheal intubation performed with the Storz C-Mac Video Laryngoscope
Group II: Direct LaryngoscopyActive Control1 Intervention
Nasotracheal Intubation performed with the standard clinical direct blades

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
706 Previous Clinical Trials
8,570,040 Total Patients Enrolled
Children's Hospital ColoradoOTHER
114 Previous Clinical Trials
5,126,135 Total Patients Enrolled
Seattle Children's HospitalOTHER
300 Previous Clinical Trials
5,215,265 Total Patients Enrolled

Media Library

Nasotracheal Intubation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05433155 — N/A
Intubation Difficulty Research Study Groups: Videolaryngoscopy, Direct Laryngoscopy
Intubation Difficulty Clinical Trial 2023: Nasotracheal Intubation Highlights & Side Effects. Trial Name: NCT05433155 — N/A
Nasotracheal Intubation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05433155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count in this clinical experiment?

"Affirmative. It is evident from the information available on clinicaltrials.gov that this research project began to recruit participants on June 6th 2022 and was recently refreshed on December 5th 2022. The study necessitates 1400 patients across 8 medical sites."

Answered by AI

Am I an eligible participant in this medical experiment?

"To participate in this medical trial, patients must have anoxia and be younger than a year old. The study is hoping to enroll up to 1400 individuals."

Answered by AI

Is this research project enrolling participants at the present time?

"Indeed, the information on clinicaltrials.gov demonstrates that this study is actively engaging with potential participants. It was initially posted on June 6th 2022 and recently updated in December 5th of the same year. The research requires 1400 patients from 8 distinct sites to partake in this trial."

Answered by AI

How many venues are administering this research study?

"There are 8 locations that are presently enrolling participants, including Seattle Children's Hospital in Washington, Dell Children's Medical Center in Texas and Emory University in Georgia. Additionally, there 5 other sites offering this trial."

Answered by AI

Are individuals above the age of 30 eligible to take part in this investigation?

"This clinical trial is seeking participants who are between 1 and 365 days of age."

Answered by AI
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~420 spots leftby Dec 2024