Trial Outcomes & Findings for Endotracheal Tube Holder and Bite Guard Research (NCT NCT02347488)
NCT ID: NCT02347488
Last Updated: 2017-04-17
Results Overview
The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.
COMPLETED
PHASE4
30 participants
5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).
2017-04-17
Participant Flow
Participant milestones
| Measure |
Tape, Followed by ETT Holder and Bite Guard
Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.
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|---|---|
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Overall Study
STARTED
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30
|
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Overall Study
COMPLETED
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30
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endotracheal Tube Holder and Bite Guard Research
Baseline characteristics by cohort
| Measure |
Tape, Followed by ETT Holder and Bite Guard
n=30 Participants
Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.
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|---|---|
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Age, Continuous
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55.4 years
n=93 Participants
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Sex: Female, Male
Female
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16 Participants
n=93 Participants
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Sex: Female, Male
Male
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14 Participants
n=93 Participants
|
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Region of Enrollment
United States
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30 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.
Outcome measures
| Measure |
Adhesive Tape
n=30 Participants
Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
|
Haider ETT Tube Holder
n=30 Participants
Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
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|---|---|---|
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Change in ETT Position
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3.4 centimeters
Standard Deviation 1.8
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0.3 centimeters
Standard Deviation 0.6
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SECONDARY outcome
Timeframe: Immediately after surgery and 1-3 days following surgery, before discharge.Population: 29 patients returned the survey (one patient was aphasic post-op and could not compete the survey)
The patients were examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient suffered any irritation or minor injury to the face and oral structures. The patients were asked to fill out a questionnaire after recovery with questions about their overall experience with specific relation to any irritation and/or minor trauma to their face, oral structures, throat, jaw, and temporomandibular joint.
Outcome measures
| Measure |
Adhesive Tape
n=29 Participants
Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
|
Haider ETT Tube Holder
Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
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|---|---|---|
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Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device
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2 Participants
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—
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SECONDARY outcome
Timeframe: 5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)Number of participants experiencing ETT movement \>1cm under each fixation technique
Outcome measures
| Measure |
Adhesive Tape
n=30 Participants
Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
|
Haider ETT Tube Holder
n=30 Participants
Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
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|---|---|---|
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Clinically Significant Movement
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29 Participants
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1 Participants
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SECONDARY outcome
Timeframe: 5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)Number of participants experiencing ETT movement \>4cm under each fixation technique
Outcome measures
| Measure |
Adhesive Tape
n=30 Participants
Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
|
Haider ETT Tube Holder
n=30 Participants
Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
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|---|---|---|
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Potentially High Extubation Risk
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9 Participants
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0 Participants
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Adverse Events
Tape, Followed by ETT Holder and Bite Guard
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tape, Followed by ETT Holder and Bite Guard
n=30 participants at risk
Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.
Adverse events were not reported "per arm" because surgery patients were assessed for adverse events after experiencing both methods.
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|---|---|
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Gastrointestinal disorders
Mild discomfort of the gum
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3.3%
1/30 • Number of events 1 • Immediately after surgery and up to 1-3 days following surgery, before discharge.
Unfavorable findings were recorded as adverse events in this study only if severe, unexpected, or considered to have been attributable to use of the study device.
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Injury, poisoning and procedural complications
minor abrasion of the tongue frenulum
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3.3%
1/30 • Number of events 1 • Immediately after surgery and up to 1-3 days following surgery, before discharge.
Unfavorable findings were recorded as adverse events in this study only if severe, unexpected, or considered to have been attributable to use of the study device.
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Additional Information
Nir Nahum Hoftman, MD
UCLA Department of Anesthesiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place