N/A Completed N=140 Randomized Single-blind Supportive Care

Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

Difficult Endotracheal Intubation

Source: ClinicalTrials.gov NCT01215695 ↗

Enrolled (actual)

140

Serious AEs

2.9%

Results posted

Jul 2017

Primary outcomePrimary: Intubation Time — 66; 71 time in seconds — p=<0.05

Summary

We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).

Outcome Measures

Outcome	Result	p-value
PRIMARY Intubation Time	66; 71	<0.05 sig
SECONDARY The Number of Intubation Attempts	1.2; 1.1	<0.05 sig
SECONDARY Neck Movement	47; 54	0.05
SECONDARY Laryngeal View Grade of 1 or 2	62; 50	0.05
SECONDARY Ease of Intubation	36; 39	0.05

Eligibility Criteria

Inclusion Criteria

BMI > 35
Thyromental distance 43 cm at the level of the thyroid cartilage
Patients with immobilized cervical spine (C-collar in place).
History of difficult laryngoscopy or intubation

Exclusion Criteria

Full stomach
Hiatal hernia
Severe GERD (Gastroesophageal reflux disease)
Tumors of the upper airway

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01215695). 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. Informational only — not medical advice.