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NCT Number: NCT02449356

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

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.

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Key information

Conditions

Mechanical Ventilation Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wangyuan Zou

Changsha, Hunan, 410013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prone position endotracheal tube(PPT)

Device

some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wangyuan Zou

Other

Collaborators

  • Central South University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 20, 2015
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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