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

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ClinicalTrials.gov Identifier: NCT02449356
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Sponsor:
Collaborator:
Central South University
Information provided by (Responsible Party):
Wangyuan Zou, Central South University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Device: prone position endotracheal tube(PPT) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: prone position endotracheal tube(PPT)
the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.
 Device: prone position endotracheal tube(PPT)
some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes
No Intervention: traditional endotracheal tube(TT)
the subjects of this arm are given the routine endotracheal tube.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The Number of the Prolapse of Endotracheal Tube [ Time Frame: At any time within the procedure of the whole surgery ]
    Counting the number who occured the prolapse of endotracheal tube in both groups

  2. the Degree of Loose or Dampness of the Tape [ Time Frame: 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


Other Outcome Measures:
  1. the Incidence of Dysphagia [ Time Frame: within the first 24 hours after extubation ]
    count the number who suffered the dysphagia within the first 24 hours after extubation

  2. the Incidence of Sore Throat [ Time Frame: within the first 24 hour after extubation ]
    count the number who suffer sore throat within the first 24 hour after extubation

  3. the Incidence of Dysphonia [ Time Frame: within the first 24 hour after extubation ]
    count the number who suffered dysphonia within the first 24 hour after extubation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449356


Locations
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China, Hunan
Wangyuan Zou
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Wangyuan Zou
Central South University
Investigators
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Principal Investigator: Wangyuan Zou, MD,phD Xiangya Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wangyuan Zou, postgraduate tutor, Central South University
ClinicalTrials.gov Identifier: NCT02449356    
Other Study ID Numbers: 2013L14
First Posted: May 20, 2015    Key Record Dates
Results First Posted: June 15, 2017
Last Update Posted: June 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wangyuan Zou, Central South University:
Prone position ventilation
Endotracheal intubation
Displacement