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Status unknownNCT02857504Updated Apr 17, 2017

One Lung Ventilation: Double Lumen Tube

An interventional study of double lumen tube with a hook and double lumen tube without a hook in Double Lumen Tube, sponsored by University Medical Centre Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-17.

Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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)(1).

OLV can be provided by double lumen tube (DLT) or bronchial blocker. There are advantages and disadvantages of both techniques, but DLT is more recommended because it allows total emptying of the operated lung. Air and secretion can be aspirated through the wide lumen of the tube during the surgery (2, 3).

There are many kinds of DLT which differ according to shape and material. Most commonly used are left sided DLT which are placed into left main bronchus and right or left lungs can be closed or emptied. Left sided tube have a hook which is placed on the carina to prevent displacement of the tube. There are also DLT without the hook which are more gentle and easier to place in the left main bronchus (4,5). After the insertion of the left tube without the hook, bronchoscopy is recommended to check the position of the tube (6,7,8,9).

Some severe complications (injury of the bronchial tree) after insertion of the hooked tube are found in the literature (10). The investigators have published such complication from our experience (11).

Each anesthesiologist decides individually which kind of DLT to use as there are no studies which have objectivised the advantage of either technique. There is only one study where they have compared both techniques but they have found no difference. That is why the investigators decided to study which technique is better so this can be included in our standard operative procedure.

02

Conditions studied

  • Double Lumen Tube

Keywords

  • double lumen tube
  • hook
03

In context

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ASA>3,
  • severe heart illness (NYHA >3),
  • severe pulmonary obstructive disease (FEV1\<40%),
  • neurologic disorders and
  • patients with other respiratory or lung disease.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    double lumen tube with a hook

    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

  • Other
    double lumen tube without a hook

    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

  • Devicedouble lumen tube with a hook

    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.

  • Devicedouble lumen tube without a hook

    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.

06

What researchers measure

Primary outcomes

  1. intubation

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

    Time frame: intraoperative

07

Study locations

1 of 1 sites recruiting
  • University Medical Center Ljubljana
    Ljubljana, 1000, Slovenia
    Recruiting
08

References and documents

Publications

  • Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7. PubMed 19752725 ↗
  • 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. PubMed 23089502 ↗
  • 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. PubMed 11932162 ↗
  • 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. PubMed 18945364 ↗
  • 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. PubMed 9477054 ↗
  • 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. PubMed 2520925 ↗
  • 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. PubMed 17021522 ↗
  • 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. PubMed 10392687 ↗
  • 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. PubMed 25489763 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02857504
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Lea Andjelkovic (MD, University Medical Centre Ljubljana) — Principal investigator
First posted
Aug 5, 2016
Start date
Mar 2016
Primary completion
Apr 2017 (estimated)
Completion
Apr 2017 (estimated)
Last update
Apr 17, 2017

Study contacts

Lea Andjelkovic, MD
Contact
lea.andjelkovic@gmail.com
0038641254978

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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