Trial Outcomes & Findings for Flexible Intubation Scope With or Without Video Laryngoscope in Supporting Endotracheal Tube Placement in Patients With Head and Neck Cancer Before Surgery (NCT NCT03757091)

Results Overview

Defined as the number of participants with any of the following during initial intubation attempt.1 Intubation time exceeding 60 seconds, 2. Failure to intubate on the first attempt, 3. Provider assessment of intubation as difficult or unsuccessful.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

143 participants

Primary outcome timeframe

intubation time, up to 3 minutes

Results posted on

2026-01-22

Participant Flow

The Main OR procedure daily schedule will be used for patient selection. Once eligibility of a study candidate has been identified, the study coordinator will be informed to start the patient interview and obtain written informed consent.

Participant milestones

Participant milestones
Measure	Flexible Intubation Scope (FIS) control group will utilize FIS (flexible intubation scope)	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)
Overall Study STARTED	69	66
Overall Study COMPLETED	64	58
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flexible Intubation Scope (FIS) n=69 Participants control group will utilize FIS (flexible intubation scope)	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) n=66 Participants treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=69 Participants	0 Participants n=66 Participants	0 Participants n=135 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=69 Participants	41 Participants n=66 Participants	77 Participants n=135 Participants
Age, Categorical >=65 years	33 Participants n=69 Participants	25 Participants n=66 Participants	58 Participants n=135 Participants
Age, Continuous	63.20 years STANDARD_DEVIATION 11.84 • n=69 Participants	59.26 years STANDARD_DEVIATION 13.97 • n=66 Participants	61.23 years STANDARD_DEVIATION 12.905 • n=135 Participants
Sex: Female, Male Female	30 Participants n=69 Participants	27 Participants n=66 Participants	57 Participants n=135 Participants
Sex: Female, Male Male	39 Participants n=69 Participants	39 Participants n=66 Participants	78 Participants n=135 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	69 participants n=69 Participants	66 participants n=66 Participants	135 participants n=135 Participants

PRIMARY outcome

Timeframe: intubation time, up to 3 minutes

Defined as the number of participants with any of the following during initial intubation attempt.1 Intubation time exceeding 60 seconds, 2. Failure to intubate on the first attempt, 3. Provider assessment of intubation as difficult or unsuccessful.

Outcome measures

Outcome measures
Measure	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) n=63 Participants treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)	Flexible Intubation Scope (FIS) n=67 Participants control group will utilize FIS (flexible intubation scope)
Difficult Endotracheal Tube (ETT) Placement Yes	29 Participants	40 Participants
Difficult Endotracheal Tube (ETT) Placement No	34 Participants	27 Participants

SECONDARY outcome

Timeframe: time captured when FIS passed the lips to CO2 confirmation

Time from induction to successful intubation

Outcome measures

Outcome measures
Measure	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) n=58 Participants treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)	Flexible Intubation Scope (FIS) n=64 Participants control group will utilize FIS (flexible intubation scope)
Intubation Time	50.92 seconds Interval 44.04 to 57.8	58.37 seconds Interval 51.44 to 65.3

SECONDARY outcome

Timeframe: intubation time, up to 3 minutes

Number of Intubation Attempts

Outcome measures

Outcome measures
Measure	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) n=58 Participants treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)	Flexible Intubation Scope (FIS) n=64 Participants control group will utilize FIS (flexible intubation scope)
Number of Intubation Attempts 1	54 Participants	50 Participants
Number of Intubation Attempts 2 or more	4 Participants	14 Participants

SECONDARY outcome

Timeframe: during intubation process/attempt

Failed Airway Rate

Outcome measures

Outcome measures
Measure	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) n=58 Participants treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)	Flexible Intubation Scope (FIS) n=64 Participants control group will utilize FIS (flexible intubation scope)
Rate of Failure at Intubation	1.72 percentage of participants Interval 0.42 to 11.91	7.81 percentage of participants Interval 7.76 to 26.86

SECONDARY outcome

Timeframe: duration of intubation attempt

The number of people who had 1= extremely easy, 2=somewhat easy, 3=resistance, 4= difficult, 5= unsuccessful (for both groups)

Outcome measures

Outcome measures
Measure	Flexible Intubation Scope + Video Laryngoscope (FIS+VL) n=64 Participants treatment group will utilize FIS+VL (flexible intubation scope + video laryngoscope)	Flexible Intubation Scope (FIS) n=67 Participants control group will utilize FIS (flexible intubation scope)
Ease of Intubation (Provider Assessment) 1= extremely easy	40 Participants	31 Participants
Ease of Intubation (Provider Assessment) 2=somewhat easy	14 Participants	14 Participants
Ease of Intubation (Provider Assessment) 3=resistance	6 Participants	9 Participants
Ease of Intubation (Provider Assessment) 4= difficult	2 Participants	2 Participants
Ease of Intubation (Provider Assessment) 5= unsuccessful	2 Participants	11 Participants

Adverse Events

Flexible Intubation Scope (FIS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Flexible Intubation Scope + Video Laryngoscope (FIS+VL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carin Hagberg

The University of Texas MD Anderson Cancer Center

Phone: (713) 745-4495

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place