N/A
N=566
The Videolaryngoscopy in Small Infants
Surgery · Anesthesia, Endotracheal
Bottom Line
View on ClinicalTrials.gov: NCT03396432 ↗Enrolled (actual)
566
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Success in the First Attempt — 253; 243 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Video Laryngoscopy for ET placement (Device); Direct Laryngoscopy for ET Placement (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Success in the First Attempt |
253; 243 | — |
| SECONDARY Hypoxia |
9; 15 | — |
Summary
Complications related to infant (≤ 1 year) airway management are under-appreciated because of few rigorous and targeted studies. Investigators have recently shown that multiple tracheal intubation (TI) attempts are a key risk factor for intubation-related complications in small children. Tracheal Intubation using Video laryngoscopy (VL) has become popular in anesthesiology practice because of several advantages over conventional direct laryngoscopy (DL). Studies show that VL improves the view of the airway compared to DL, requires fewer intubation attempts, but may take more time to intubate the trachea. This study compares first attempt success of VL to DL in infants presenting for elective surgery.
Eligibility Criteria
Inclusion Criteria
- Males or females age 0 to <12 months.
- Scheduled for non-cardiac surgery or procedure lasting longer than 30 minutes under general anesthesia where oral endotracheal intubation will be performed by an anesthesiology clinician.
- Subject/Parental/guardian permission (informed consent).
Inclusion for clinician participants:
- Pediatric anesthesia attending, pediatric anesthesia fellows, and anesthesia resident
Exclusion Criteria
- History of difficult intubation
- History with abnormal airway
- Predictive of difficult intubation upon physical examination
- Parents/guardians who, in the opinion of the investigator, may be unable to understand or give informed consent
Data sourced from ClinicalTrials.gov (NCT03396432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.