NCT02449356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 15, 2017

Completed
Last Updated

June 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

April 26, 2015

Results QC Date

December 7, 2016

Last Update Submit

March 30, 2017

Conditions

Mechanical Ventilation Complication

Keywords

Prone position ventilationEndotracheal intubationDisplacement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Other Outcomes (3)

  • the Incidence of Dysphagia

    within the first 24 hours after extubation

  • the Incidence of Sore Throat

    within the first 24 hour after extubation

  • the Incidence of Dysphonia

    within the first 24 hour after extubation

Study Arms (2)

prone position endotracheal tube(PPT)

EXPERIMENTAL

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

Device: prone position endotracheal tube(PPT)

traditional endotracheal tube(TT)

NO INTERVENTION

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

Interventions

prone position endotracheal tube(PPT)DEVICE

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

prone position endotracheal tube(PPT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wangyuan Zou

Changsha, Hunan, 410013, China

Location

Related Publications (9)

  • 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.

    PMID: 18211991BACKGROUND

  • 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.

    PMID: 8251716BACKGROUND

  • 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.

    PMID: 21286458BACKGROUND

  • 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.

    PMID: 17510044BACKGROUND

  • 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.

    PMID: 18359427BACKGROUND

  • 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.

    PMID: 20473258BACKGROUND

  • 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.

    PMID: 20130832BACKGROUND

  • 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.

    PMID: 23216936BACKGROUND

  • 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.

    PMID: 28496141DERIVED

Limitations and Caveats

No limitations and caveats.

Results Point of Contact

Title
Jiali Shao
Organization
Xiangya Hospital
zwyfeng@163.com
+8684327413

Study Officials

  • Wangyuan Zou, MD,phD

    Xiangya Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
postgraduate tutor

Study Record Dates

First Submitted

April 26, 2015

First Posted

May 20, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

June 15, 2017

Results First Posted

June 15, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)