Overview

This trial is active, not recruiting.

Condition anticipated difficult airway
Treatments lingual traction, sham, fiberoptic intubation
Sponsor Enrico Camporesi
Start date June 2012
End date September 2013
Trial size 78 participants
Trial identifier NCT01958346, Pro00008289

Summary

We propose the additional technique of lingual traction or "tongue pulling" in conjunction with use of the flexible fiberoptic bronchoscope for facilitating successful first attempts at and decreasing time to intubation of the difficult airway and rescuing otherwise failed intubation attempts. Induction of general anesthesia causes relaxation and approximation of the soft palate, base of the tongue, epiglottis, and posterior pharyngeal wall, creating unfavorable anatomic changes in the pharynx for successful intubation. The use of lingual traction can assist in diminishing these problems by clearing the tongue away from the soft palate and uvula and lifting the epiglottis from the posterior pharyngeal wall, especially in the unanticipated difficult airway patient.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Sham Comparator)
sham
Standard of care fiberoptic intubation without any additional experimental maneuvers
fiberoptic intubation
(Experimental)
lingual traction
The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
fiberoptic intubation

Primary Outcomes

Measure
Number of successful intubations on first attempt
time frame: At Intubation

Secondary Outcomes

Measure
Sore throat grade on first postoperative day
time frame: Postoperative day one

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - > 18 years old - With ASA (American Society of Anesthesiologists) physical status I-III - With anticipated difficult airway - Scheduled for elective surgery requiring orotracheal intubation (populations such as elective hip and knee arthroplasty patients) - Provide written consent Exclusion Criteria: - With (American Society of Anesthesiologists) ASA physical status IV - Pregnant - Require rapid-sequence induction - Require a non-standard tracheal tub - Unable to provide written consent - At risk for pulmonary aspiration of gastric content

Additional Information

Official title New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway: A Prospective, Randomized Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University of South Florida.