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

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication
• Interventions: Device: prone position endotracheal tube(PPT)

• Registration Number: NCT02449356
• Lead Sponsor: Wangyuan Zou

Brief Summary

In this study, the investigators adopt the special endotracheal tube to those patients at prone posture during the operation,or those with acute respiratory distress syndrome in the intensive care unit(ICU), so that the investigators can reduce, or even avoid some severe complications during perianesthesia, and that the investigators can provide strong safeguard measures for the respiratory therapy of critical patients in ICU.

Detailed Description

The investigators apply some technical proposals to make it come true:one kind of special endotracheal tube, including traditional endotracheal tube,fixed device,fixed rope,two through holes.With this tube ,the investigators can keep away shifting and falling off of traditional air tube,so that the investigators can try to avoid disaster events.And for the patients with acute respiratory disease syndrome(ARDS),they are always given ventilation in prone position,so it may be beneficial.

Study Timeline

• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-05-16
• Study First Posted: 2015-05-20
• Study Start: 2015-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2016-12-07
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-30
• Last Update Submitted: 2017-03-30
• Results First Posted: 2017-06-15
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• those who are about to undergo the surgery at prone posture,especially in neurosurgery and spine surgery，American society of anesthesia(ASA) grade I-II，aged from 18 to 65 years old,weight ranged from 50 to 75 kilograms.

Exclusion Criteria

• No meeting inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prone position endotracheal tube(PPT)	prone position endotracheal tube(PPT)	the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.

Primary Outcome Measures

Name	Time	Method
Displacement of the Endotracheal Tube	Participants were followed for the duration of surgery, an average of 2 hours.	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).

Secondary Outcome Measures

Name	Time	Method
The Number of the Prolapse of Endotracheal Tube	At any time within the procedure of the whole surgery	Counting the number who occured the prolapse of endotracheal tube in both groups
the Degree of Loose or Dampness of the Tape	at the time when patients were turning to supine position	counting and quantifying the number who occured the dampness or loose of the tape in both groups

Trial Locations

Locations (1)

Wangyuan Zou; 🇨🇳 Changsha, Hunan, China