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Clinical Trials/NCT02449356
NCT02449356CompletedNot Applicable

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

Wangyuan Zou1 site in 1 country60 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Displacement of the Endotracheal Tube

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

prone position endotracheal tube(PPT)

Experimental

the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.

Intervention: prone position endotracheal tube(PPT) (Device)

traditional endotracheal tube(TT)

No Intervention

the subjects of this arm are given the routine endotracheal tube.

Outcomes

Primary Outcomes

Displacement of the Endotracheal Tube

Time Frame: 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 Outcomes

  • The Number of the Prolapse of Endotracheal Tube(At any time within the procedure of the whole surgery)
  • the Degree of Loose or Dampness of the Tape(at the time when patients were turning to supine position)

Investigators

Sponsor
Wangyuan Zou
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Wangyuan Zou

postgraduate tutor

Central South University

Study Sites (1)

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