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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02449356
• Other study ID #: 2013L14
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 26, 2015
• Last updated: May 20, 2015
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

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 ARDS,they are always given ventilation in prone position,so it may be beneficial.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• those who are about to undergo the surgery at prone posture,especially in neurosurgery and spine surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• prone ventilation endotracheal tube
some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes

Locations

Country	Name	City	State
China	Wangyuan Zou	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Wangyuan Zou	Central South University

Country where clinical trial is conducted

China, 

References & Publications (8)

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:S45-8. doi: 10.4097/kjae.2010.59.S.S45. Epub 2010 Dec 31. — View Citation

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. Review. — View Citation

Gattinoni L, Carlesso E, Taccone P, Polli F, Guérin 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. Review. — View Citation

Korn S, Schubert A, Barnett G. Endotracheal tube obstruction during stereotactic craniotomy. J Neurosurg Anesthesiol. 1993 Oct;5(4):272-5. — View Citation

Soundararajan N, Cunliffe M. Anaesthesia for spinal surgery in children. Br J Anaesth. 2007 Jul;99(1):86-94. Epub 2007 May 17. Review. — View Citation

Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guérin 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. Review. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the incidence of sore throat	count the number who suffer sore throat	within the first 24 hour after surgery	No
Other	the order of severity of sore throat	divide into different groups by the order of severity of sore throat	within the first 24 hour after surgery	No
Other	the incidence of dysphagia	count the number who suffer dysphagia	within the first 24 hour after surgery	No
Other	the order of severity of dysphagia	divide into different groups by the order of severity of dysphagia	within the first 24 hour after surgery	No
Other	the incidence of dysphonia	count the number who suffer dysphonia	within the first 24 hour after surgery	No
Other	the order of severity of dysphonia	divide into different groups by the order of severity of dysphonia	within the first 24 hour after surgery	No
Primary	the incidence of loose of the adhesive tape	count the number whose adhesive tape loose	during the operation	No
Primary	the order of severity of loose of the adhesive tape	divide into different groups by the order of severity of loose of the adhesive tape	during the operation	No
Secondary	the incidence of the displacement of the endotracheal tube	count the number whose endotracheal tube shifting	during the operation	No
Secondary	the order of severity of the displacement of the endotracheal tube	divide into different groups by the order of severity of the displacement of the endotracheal tube	during the operation	No
Secondary	the incidence of the prolapse of the endotracheal tube	count the number whose endotracheal tube prolapsing	during the operation	No
Secondary	the order of severity of the prolapse of the endotracheal tube	divide into different groups by the order of severity of the prolapse of the endotracheal tube	during the operation	No