Trial Outcomes & Findings for Force of Endotracheal Tube Extubation; Esophagus vs. Trachea (NCT NCT03480425)
NCT ID: NCT03480425
Last Updated: 2020-05-14
Results Overview
Force (N) of resistance to pulling the tube out compared for esophageal versus tracheal intubation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2020-05-14
Participant Flow
Participant milestones
| Measure |
Intubated Patient
Esophagus, then trachea, are intentionally intubated with a cuffed endotracheal tube, the cuff inflated to \>30cm water pressure, a force transducer attached, and force of extubation recorded.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intubated Patient
Esophagus, then trachea, are intentionally intubated with a cuffed endotracheal tube, the cuff inflated to \>30cm water pressure, a force transducer attached, and force of extubation recorded.
|
|---|---|
|
Overall Study
Force transducer technical failure
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Esophageal Then Tracheal Intubated Patient
n=11 Participants
Esophagus is intentionally intubated with a cuffed endotracheal tube, the cuff inflated to \>30cm water pressure, a force transducer attached, and force of extubation recorded. Then Trachea is intentionally intubated the cuff inflated to \>30cm water pressure, and force of extubation recorded.
Measuring extubation force: Intubation of the esophagus of anesthetized participants who are having planned endotracheal intubate for surgery; inflation of the cuff; attachment of a force transducer to the tube connector; and gently tugging the tube out of the mouth. Then intubating the esophagus and repeating the tugging procedure. Meanwhile, the force of resistance to tugging is measured with a force transducer.
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 19 • n=11 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
|
height
|
170 cm
STANDARD_DEVIATION 9 • n=11 Participants
|
|
weight
|
80 kg
STANDARD_DEVIATION 19 • n=11 Participants
|
PRIMARY outcome
Timeframe: 1 yearForce (N) of resistance to pulling the tube out compared for esophageal versus tracheal intubation
Outcome measures
| Measure |
Esophagus
n=11 Participants
withdrawal force (N)
|
|---|---|
|
Withdrawal Force.
esophagus
|
6.2 Newtons
Standard Deviation 4.4
|
|
Withdrawal Force.
trachea
|
6.1 Newtons
Standard Deviation 2.0
|
Adverse Events
Intubated Patient
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place