One Lung Ventilation: Double Lumen Tube

NCT02857504 | Unknown

• 1 other identifier: 137/02/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

One lung ventilation (OLV) has become a standard procedure for the vast majority of interventions in pulmonary surgery. It is used in both techniques: thoracotomy and videothoracoscopy (VATS). OLV can be provided by double lumen tube (DLT) with or without the hook. In our study the investigators want to find out if there is any advantage with one or another.

Conditions

Double Lumen Tube

Keywords

double lumen tube; hook

Outcome Measures

Primary Outcomes (1)

• intubation

  The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured.

  intraoperative

Study Arms (2)

double lumen tube with a hook

OTHER

The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped.

Device: double lumen tube with a hook

double lumen tube without a hook

OTHER

Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left.

Device: double lumen tube without a hook

Interventions

double lumen tube with a hook DEVICE

The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped.

double lumen tube with a hook

double lumen tube without a hook DEVICE

Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left.

double lumen tube without a hook

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned thoracotomy or VATS surgical technique
• with ASA (American Society of Anesthesiologist) physical status 1-3.

You may not qualify if:

• ASA\>3,
• severe heart illness (NYHA \>3),
• severe pulmonary obstructive disease (FEV1\<40%),
• neurologic disorders and
• patients with other respiratory or lung disease.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (9)

• Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.

  PMID: 19752725 RESULT

• Pedoto A. How to choose the double-lumen tube size and side: the eternal debate. Anesthesiol Clin. 2012 Dec;30(4):671-81. doi: 10.1016/j.anclin.2012.08.001.

  PMID: 23089502 RESULT

• Hofmann HS, Rettig G, Radke J, Neef H, Silber RE. Iatrogenic ruptures of the tracheobronchial tree. Eur J Cardiothorac Surg. 2002 Apr;21(4):649-52. doi: 10.1016/s1010-7940(02)00037-4.

  PMID: 11932162 RESULT

• Prunet B, Lacroix G, Asencio Y, Cathelinaud O, Avaro JP, Goutorbe P. Iatrogenic post-intubation tracheal rupture treated conservatively without intubation: a case report. Cases J. 2008 Oct 22;1(1):259. doi: 10.1186/1757-1626-1-259.

  PMID: 18945364 RESULT

• Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.

  PMID: 9477054 RESULT

• Slinger PD. Fiberoptic bronchoscopic positioning of double-lumen tubes. J Cardiothorac Anesth. 1989 Aug;3(4):486-96. doi: 10.1016/s0888-6296(89)97987-8.

  PMID: 2520925 RESULT

• Cohen E. Double-lumen tube position should be confirmed by fiberoptic bronchoscopy. Curr Opin Anaesthesiol. 2004 Feb;17(1):1-6. doi: 10.1097/00001503-200402000-00002.

  PMID: 17021522 RESULT

• Fitzmaurice BG, Brodsky JB. Airway rupture from double-lumen tubes. J Cardiothorac Vasc Anesth. 1999 Jun;13(3):322-9. doi: 10.1016/s1053-0770(99)90273-2. No abstract available.

  PMID: 10392687 RESULT

• Dumans-Nizard V, Parquin JF, Moyer JD, Dreyfus JF, Fischler M, Le Guen M. Left double-lumen tube with or without a carinal hook: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jun;32(6):418-24. doi: 10.1097/EJA.0000000000000201.

  PMID: 25489763 RESULT

Central Study Contacts

Lea Andjelkovic, MD

CONTACT

0038641254978; lea.andjelkovic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 5, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

SL (1)