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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Device: prone position endotracheal tube(PPT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prone position endotracheal tube(PPT)<br>the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope. | Device: prone position endotracheal tube(PPT)<br>* some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes<br>|
| No Intervention: traditional endotracheal tube(TT)<br>the subjects of this arm are given the routine endotracheal tube. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Displacement of the Endotracheal Tube | 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). | Participants were followed for the duration of surgery, an average of 2 hours. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prone position ventilation, Endotracheal intubation, Displacement