Trial Outcomes & Findings for Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition (NCT NCT02449356)

Results Overview

We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance\<0.5cm),moderate(0.5cm≤displacement distance\<1.5cm),severe (1.5cm≤displacement distance).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Participants were followed for the duration of surgery, an average of 2 hours.

Results posted on

2017-06-15

Participant Flow

We have 80 adult patients as candidates who were undergoing the neurosurgery or spinal surgery in Xiangya Hospital affiliated to Central South University between Mar 11, 2014 and Mar 16, 2016. These participants were graded American society of anesthesia(ASA)I-II,and aged 30-70 years old,weighted ranging from 50 to 75 kilograms.

We finally enrolled 60 patients for our trail. Among the 80 candidates, 7 patients couldn't meet our inclusion criteria; the other 13 patients refused to participate in this trail at last.

Participant milestones

Participant milestones
Measure	Traditional Endotracheal Tube(TT) the subjects of this arm are given the routine endotracheal tube.	Prone Position Endotracheal Tube(PPT) the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prone Position Endotracheal Tube(PPT) n=30 Participants We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube.	Traditional Endotracheal Tube(TT) n=30 Participants We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49 yr STANDARD_DEVIATION 5 • n=5 Participants	47 yr STANDARD_DEVIATION 6 • n=7 Participants	48 yr STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed for the duration of surgery, an average of 2 hours.

Population: All patients in each group were analyzed

We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance\<0.5cm),moderate(0.5cm≤displacement distance\<1.5cm),severe (1.5cm≤displacement distance).

Outcome measures

Outcome measures
Measure	Prone Ventilation Endotracheal Tube n=30 Participants the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes	the Traditional Endotracheal Tube n=30 Participants the subjects of this arm are given the routine endotracheal tube.
Displacement of the Endotracheal Tube Mild displacement	0 Participants	11 Participants
Displacement of the Endotracheal Tube Severe displacement	0 Participants	3 Participants
Displacement of the Endotracheal Tube The overall incidence of displacement	0 Participants	22 Participants
Displacement of the Endotracheal Tube Moderate displacement	0 Participants	8 Participants

SECONDARY outcome

Timeframe: At any time within the procedure of the whole surgery

Population: All participants in both groups were analyzed

Counting the number who occured the prolapse of endotracheal tube in both groups

Outcome measures

Outcome measures
Measure	Prone Ventilation Endotracheal Tube n=30 Participants the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes	the Traditional Endotracheal Tube n=30 Participants the subjects of this arm are given the routine endotracheal tube.
The Number of the Prolapse of Endotracheal Tube	0 Participants	0 Participants

SECONDARY outcome

Timeframe: at the time when patients were turning to supine position

Population: all participants in both groups were analyzed

counting and quantifying the number who occured the dampness or loose of the tape in both groups

Outcome measures

Outcome measures
Measure	Prone Ventilation Endotracheal Tube n=30 Participants the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes	the Traditional Endotracheal Tube n=30 Participants the subjects of this arm are given the routine endotracheal tube.
the Degree of Loose or Dampness of the Tape	7 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 24 hours after extubation

Population: all patients were analyzed

count the number who suffered the dysphagia within the first 24 hours after extubation

Outcome measures

Outcome measures
Measure	Prone Ventilation Endotracheal Tube n=30 Participants the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes	the Traditional Endotracheal Tube n=30 Participants the subjects of this arm are given the routine endotracheal tube.
the Incidence of Dysphagia	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 24 hour after extubation

Population: all patients in both groups were analyzed

count the number who suffer sore throat within the first 24 hour after extubation

Outcome measures

Outcome measures
Measure	Prone Ventilation Endotracheal Tube n=30 Participants the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes	the Traditional Endotracheal Tube n=30 Participants the subjects of this arm are given the routine endotracheal tube.
the Incidence of Sore Throat	1 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: within the first 24 hour after extubation

Population: all patients in both groups were analyzed

count the number who suffered dysphonia within the first 24 hour after extubation

Outcome measures

Outcome measures
Measure	Prone Ventilation Endotracheal Tube n=30 Participants the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes	the Traditional Endotracheal Tube n=30 Participants the subjects of this arm are given the routine endotracheal tube.
the Incidence of Dysphonia	0 Participants	0 Participants

Adverse Events

Prone Position Endotracheal Tube

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Traditional Endotracheal Tube

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Prone Position Endotracheal Tube n=30 participants at risk there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.	Traditional Endotracheal Tube n=30 participants at risk there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
Skin and subcutaneous tissue disorders Sore throat	3.3% 1/30 • Number of events 1 • within the postoperative 24 hours the incidence rate of sore throat, hoarseness, dysphagia in both groups at 24-hour follow-up has been collected and calculated.	3.3% 1/30 • Number of events 1 • within the postoperative 24 hours the incidence rate of sore throat, hoarseness, dysphagia in both groups at 24-hour follow-up has been collected and calculated.

Additional Information

Jiali Shao

Xiangya Hospital

Phone: +8684327413

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place