Trial Outcomes & Findings for New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway (NCT NCT01958346)

NCT ID: NCT01958346

Last Updated: 2016-09-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: At Intubation
• Results posted on: 2016-09-12

Participant Flow

Participant milestones

Measure	Fiberoptic Intubation Alone Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers Fiberoptic Intubation	Fiberoptic Intubation With Lingual Traction 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
Overall Study STARTED	39	39
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

New Maneuver to Facilitate Fiberoptic Intubation for Difficult Airway

Baseline characteristics by cohort

Measure	Fiberoptic Intubation Alone n=39 Participants Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers Fiberoptic Intubation	Fiberoptic Intubation With Lingual Traction n=39 Participants 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	Total n=78 Participants Total of all reporting groups
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	39 participants n=7 Participants	78 participants n=5 Participants
Age, Continuous	55.4 years STANDARD_DEVIATION 12.5 • n=5 Participants	56.7 years STANDARD_DEVIATION 13.9 • n=7 Participants	56.2 years STANDARD_DEVIATION 13.0 • n=5 Participants

PRIMARY outcome

Timeframe: At Intubation

Outcome measures

Measure	Fiberoptic Intubation Alone n=39 Participants Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers Fiberoptic Intubation	Fiberoptic Intubation With Lingual Traction n=39 Participants 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
Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.	29 participants	36 participants

SECONDARY outcome

Timeframe: Postoperative day one

Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe

Outcome measures

Measure	Fiberoptic Intubation Alone n=39 Participants Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers Fiberoptic Intubation	Fiberoptic Intubation With Lingual Traction n=39 Participants 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
Sore Throat Grade on First Postoperative Day	10 participants	14 participants

Adverse Events

Fiberoptic Intubation Alone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fiberoptic Intubation With Lingual Traction

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fiberoptic Intubation Alone n=39 participants at risk Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers Fiberoptic Intubation	Fiberoptic Intubation With Lingual Traction n=39 participants at risk 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
Injury, poisoning and procedural complications Sore Throat	7.7% 3/39 • Number of events 3 • Post operative day 1 Sore throats were qualitatively scored by the patient as none, mild, moderate, or severe.	15.4% 6/39 • Number of events 6 • Post operative day 1 Sore throats were qualitatively scored by the patient as none, mild, moderate, or severe.

Additional Information

Devanand Mangar MD

Teamhealth Anesthesia

Phone: 813-844-4434

Email: devanandmangar@teamhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place