Clinical trial NCT02449356: Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition
Official title: Clinical Study of the Endotracheal Tube Used in Prone Position Ventilation Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: Prone position ventilation
Endotracheal intubation
Displacement
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Central South University
First posted: 2015-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Displacement of the Endotracheal Tube
timeFrame: Participants were followed for the duration of surgery, an average of 2 hours.
Secondary outcomes:
measure: The Number of the Prolapse of Endotracheal Tube
timeFrame: At any time within the procedure of the whole surgery
measure: the Degree of Loose or Dampness of the Tape
timeFrame: at the time when patients were turning to supine position
Other outcomes:
measure: the Incidence of Dysphagia
timeFrame: within the first 24 hours after extubation
measure: the Incidence of Sore Throat
timeFrame: within the first 24 hour after extubation
measure: the Incidence of Dysphonia
timeFrame: within the first 24 hour after extubation
Locations:
city: Changsha
country: China
facility: Wangyuan Zou
state: Hunan
Study officials:
affiliation: Xiangya Hospital
name: Wangyuan Zou, MD,phD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.