Hypoxia Clinical Trial
Official title:
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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04498598 -
Structural Modification In Supraglottic Airway Device
|
N/A | |
| Completed |
NCT05532670 -
N600X Low Saturation Accuracy Validation
|
||
| Enrolling by invitation |
NCT04106401 -
Intravascular Volumes in Hypoxia During Antarctic Confinement
|
N/A | |
| Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
| Not yet recruiting |
NCT05817448 -
Hypoxia-induced Autophagy in the Pathogenesis of MAP
|
||
| Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
| Terminated |
NCT02801162 -
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
|
N/A | |
| Not yet recruiting |
NCT02201875 -
Intrinsic Periodic Pattern of Breathing
|
N/A | |
| Completed |
NCT02943863 -
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
|
N/A | |
| Completed |
NCT01922401 -
Inverse Ratio Ventilation on Bariatric Operation
|
N/A | |
| Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
| Active, not recruiting |
NCT01681238 -
Goal-directed Therapy in High-risk Surgery
|
N/A | |
| Completed |
NCT01463527 -
Using Capnography to Reduce Hypoxia During Pediatric Sedation
|
N/A | |
| Completed |
NCT01507623 -
Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
|
N/A | |
| Withdrawn |
NCT00638040 -
The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression
|
N/A | |
| Active, not recruiting |
NCT06097754 -
Intermittent Exogenous Ketosis (IEK) at High Altitude
|
N/A | |
| Completed |
NCT04589923 -
The VISION-Acute Study
|
||
| Completed |
NCT05044585 -
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
|
N/A | |
| Completed |
NCT03659513 -
The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
|
||
| Completed |
NCT03221387 -
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
|
N/A |