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

NCT ID: NCT02449356

Last Updated: 2017-06-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

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.

Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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prone position endotracheal tube(PPT)

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

Group Type EXPERIMENTAL

prone position endotracheal tube(PPT)

Intervention Type DEVICE

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

traditional endotracheal tube(TT)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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prone position endotracheal tube(PPT)

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

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role collaborator

Wangyuan Zou

OTHER

Sponsor Role lead

Responsible Party

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Wangyuan Zou

postgraduate tutor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wangyuan Zou, MD,phD

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital

Locations

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Wangyuan Zou

Changsha, Hunan, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 18211991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8251716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21286458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17510044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18359427 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20473258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20130832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23216936 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28496141 (View on PubMed)

Other Identifiers

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2013L14

Identifier Type: -

Identifier Source: org_study_id

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