Double Lumen TubeNCT02857504
One Lung Ventilation: Double Lumen Tube
A study testing double lumen tube with a hook and double lumen tube without a hook in people with Double Lumen Tube, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double Lumen Tube
- What is being tested?
- double lumen tube with a hook and double lumen tube without a hook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned thoracotomy or VATS surgical technique
- with ASA (American Society of Anesthesiologist) physical status 1-3.
Who cannot join
- ASA>3,
- severe heart illness (NYHA >3),
- severe pulmonary obstructive disease (FEV1<40%),
- neurologic disorders and
- patients with other respiratory or lung disease.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana
Ljubljana, 1000
Lea Andjelkovic, MD, 0038641254978, lea.andjelkovic@gmail.com
About this study
Official title: One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook
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.
- Conditions
- Double Lumen Tube
- Being tested
- double lumen tube with a hook, double lumen tube without a hook
- Keywords
- double lumen tube, hook
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double lumen tube with a hookDevice
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 without a hookDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: double lumen tube without a hook |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation
The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Double Lumen TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lea Andjelkovic, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857504
- Sponsor's protocol ID
- 137/02/15
- Status last verified
- Apr 2017
- First submitted
- 29 Jul 2016
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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 19752725Pedoto 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 23089502Hofmann 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 11932162Prunet 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 18945364Klein 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 9477054Slinger 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 2520925Cohen 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 17021522Fitzmaurice 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 10392687Dumans-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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Lung Ventilation: Double-lumen Tube With vs Without Carinal Hook
- ClinicalTrials.gov ID
- NCT02857504
- Acronym / sponsor ID
- 137/02/15
- Conditions
- Double Lumen Tube
- Keywords
- double lumen tube, hook
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double lumen tube with a hook | Other | Device: double lumen tube with a hookThe 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 without a hook | Other | Device: double lumen tube without a hookTube 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned thoracotomy or VATS surgical technique
- with ASA (American Society of Anesthesiologist) physical status 1-3.
Key exclusion criteria (5 listed)
- ASA>3,
- severe heart illness (NYHA >3),
- severe pulmonary obstructive disease (FEV1<40%),
- neurologic disorders and
- patients with other respiratory or lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| double lumen tube with a hookThe 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 hookTube 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 |
Primary outcome
intubation
Time frame: intraoperative
The time needed for tube insertion (time from seeing the vocal cords to final position of the tube) was measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Results publication: PubMed 19752725Campos JH. Lung isolation techniques for patients with difficult airway. Curr Opin Anaesthesiol. 2010 Feb;23(1):12-7. doi: 10.1097/ACO.0b013e328331e8a7.
- Results publication: PubMed 23089502Pedoto 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.
- Results publication: PubMed 11932162Hofmann 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.
- Results publication: PubMed 18945364Prunet 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.
- Results publication: PubMed 9477054Klein 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.
- Results publication: PubMed 2520925Slinger 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.
- Results publication: PubMed 17021522Cohen 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.
- Results publication: PubMed 10392687Fitzmaurice 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.
- Results publication: PubMed 25489763Dumans-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing double lumen tube with a hook and double lumen tube without a hook in people with Double Lumen Tube, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lea Andjelkovic, MD (0038641254978, lea.andjelkovic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02857504, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.