Trial Outcomes & Findings for RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope (NCT NCT01965938)
NCT ID: NCT01965938
Last Updated: 2017-01-05
Results Overview
Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
usually <100 seconds
Results posted on
2017-01-05
Participant Flow
Participant milestones
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope
Baseline characteristics by cohort
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 15 • n=5 Participants
|
49 years
STANDARD_DEVIATION 12 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Gender
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Mallampati Class (N)
Class 1
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Mallampati Class (N)
Class 2
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Mallampati Class (N)
Class 3
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Mallampati Class (N)
Class 4
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Anticipated Difficult airway
Yes
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Anticipated Difficult airway
No
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: usually <100 secondsTime (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.
Outcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Time Until Proper Endotracheal Tube Placement
|
49 seconds
Interval 24.0 to 73.0
|
64 seconds
Interval 40.0 to 120.0
|
SECONDARY outcome
Timeframe: <100 secondsSuccessful intubation defined as confirming tube placement by the presence of etCO2;
Outcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Number of Participants With Successful Intubation
|
20 participants
|
20 participants
|
SECONDARY outcome
Timeframe: <100 secondsOutcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Number of Attempts Performed During Airway Management
|
1.1 number attempts
Standard Deviation 0.3
|
1.2 number attempts
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: <100 secondsPopulation: data was not collected
According to McCormack and Lehane
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: <100 secondsNumber of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc
Outcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist
|
2 participants
|
16 participants
|
SECONDARY outcome
Timeframe: <100 secondsLowest pulse oximetry saturation value reading collected from any participant during intubation
Outcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Lowest Pulse Oximetry Saturation Value Reading During Intubation
|
100 percentage of saturated hemoglobin
|
100 percentage of saturated hemoglobin
|
SECONDARY outcome
Timeframe: <100 secondsOutcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Alternate Device Used
|
0 number times an alternate device used
|
0 number times an alternate device used
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursNumber of patients with any notation of any trauma to lips, teeth, soft tissue, etc.
Outcome measures
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 Participants
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 Participants
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Oropharyngeal Injuries
|
2 participants
|
3 participants
|
Adverse Events
RIFL (Rigid and Flexing Laryngoscope)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fiberoptic Bronchoscope
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RIFL (Rigid and Flexing Laryngoscope)
n=20 participants at risk
RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
Fiberoptic Bronchoscope
n=20 participants at risk
Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Oropharyngeal injuries
|
10.0%
2/20 • Number of events 2 • During hospital stay (approximately 1-4 days)
|
15.0%
3/20 • Number of events 3 • During hospital stay (approximately 1-4 days)
|
Additional Information
Dr. Bret Alvis, MD
Vanderbilt University School of Medicine
Phone: 615-343-6268
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place