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

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

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

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 year

Force (N) of resistance to pulling the tube out compared for esophageal versus tracheal intubation

Outcome measures

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

Dr. William P. McKay

University of Saskatchewan

Phone: 306 250 5344

Results disclosure agreements

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