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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Device: prone position endotracheal tube(PPT)

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Wangyuan Zou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Incidence of Dysphagia	count the number who suffered the dysphagia within the first 24 hours after extubation	within the first 24 hours after extubation
the Incidence of Sore Throat	count the number who suffer sore throat within the first 24 hour after extubation	within the first 24 hour after extubation
the Incidence of Dysphonia	count the number who suffered dysphonia within the first 24 hour after extubation	within the first 24 hour after extubation

Collaborators and Investigators

• Sponsor: Wangyuan Zou
• Collaborators: Central South University
• Investigators: Principal Investigator: Wangyuan Zou, MD,phD, Xiangya Hospital

Publications and helpful links

General Publications

• Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
• Korn S, Schubert A, Barnett G. Endotracheal tube obstruction during stereotactic craniotomy. J Neurosurg Anesthesiol. 1993 Oct;5(4):272-5. doi: 10.1097/00008506-199310000-00008.
• Choi RM, Yoon JS, Noh JH, Kang KO, Ryu SW, Jun HJ, Cho SS. Airway obstruction by extrinsic tracheal compression during spinal surgery under prone position -A case report-. Korean J Anesthesiol. 2010 Dec;59 Suppl(Suppl):S45-8. doi: 10.4097/kjae.2010.59.S.S45. Epub 2010 Dec 31.
• Soundararajan N, Cunliffe M. Anaesthesia for spinal surgery in children. Br J Anaesth. 2007 Jul;99(1):86-94. doi: 10.1093/bja/aem120. Epub 2007 May 17.
• Tiruvoipati R, Bangash M, Manktelow B, Peek GJ. Efficacy of prone ventilation in adult patients with acute respiratory failure: a meta-analysis. J Crit Care. 2008 Mar;23(1):101-10. doi: 10.1016/j.jcrc.2007.09.003.
• Gattinoni L, Carlesso E, Taccone P, Polli F, Guerin C, Mancebo J. Prone positioning improves survival in severe ARDS: a pathophysiologic review and individual patient meta-analysis. Minerva Anestesiol. 2010 Jun;76(6):448-54.
• Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
• Zou W, Zhang W, Li X, Guo Q. A randomized crossover comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in pediatric patients undergoing prone position surgery. Paediatr Anaesth. 2013 Jan;23(1):98-100. doi: 10.1111/pan.12068. No abstract available.
• Zou W, Shao J, Liang X, Li L, He Z, Guo Q. A randomized comparison of the prone ventilation endotracheal tube versus the traditional endotracheal tube in adult patients undergoing prone position surgery. Sci Rep. 2017 May 11;7(1):1769. doi: 10.1038/s41598-017-02006-6.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 26, 2015
• First Submitted That Met QC Criteria: May 16, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Endotracheal intubation; Prone position ventilation; Displacement
• Other Study ID Numbers: 2013L14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No