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Clamping the Double Lumen Tube (C-TDL)

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ClinicalTrials.gov Identifier: NCT03508050
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jean Bussières, Laval University

Brief Summary:

Nowadays, lung isolation techniques are an essential part of thoracic anesthesia. The two principal devices used in order to achieve one-lung ventilation (OLV) are the double lumen tube (DLT) and the bronchial blocker (BB). Even though DLT and BB have always been considered equally effective in lung isolation, a study recently published by Bussières et al. demonstrated the clear superiority of BB over DLT in terms of rapidity and quality of lung collapse. In order to explain this result, a physiologic study was recently conducted. During this project, some interesting discoveries were made. In fact, during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening. Moreover, an absorption of ambient air through the lumen of the DLT or through the internal channel of the BB is observed. Putting all these elements together, a possible explanation for the superiority of BB over DLT was obtained. Indeed, in the first study of Bussières, the internal channel of BB was occluded. By doing so, there were no possible aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during lung collapse by reducing NVL volume and by conserving a higher alveolar partial pressure of oxygen in it.

The hypothesis is that when using a DLT in OLV, occluding the non-ventilated lung (NVL) lumen will reproduce the BB physiology by accelerating the second phase of lung deflation and giving a better quality of lung collapse compared to usual practice of keeping the non-ventilated lung opened to ambient air.

The main objective is to compare the speed and quality of complete lung deflation occurring during OLV with a DLT when the non-ventilated DLT lumen is occluded vs not occluded.

This randomized study will include a total of 30 patients scheduled for lung resection using video-assisted thoracoscopic surgery (VATS). Fifteen patients will compose the experimental group (NVL lumen occluded) and 15 other patients will be part of the control group (NVL lumen opened to ambient air).


Condition or disease Intervention/treatment Phase
One-lung Ventilation Device: Clamping the Double Lumen Tube Not Applicable

Detailed Description:

One-lung ventilation (OLV) is a major consideration in thoracic anesthesia. Lung isolation, through the use of double-lumen tube (DLT) or bronchial blocker (BB), offers to the surgeon the intra-thoracic access he needs for the surgery. With the use of a DLT, the non-ventilated lung is isolated by disconnecting its specific lumen from the ventilator and keeping it opened to ambient air. With a BB, the BB cuff is inflated in the bronchus after a brief apnea period. Thereafter, only the dependent lung is ventilated.

Until recently, studies evaluating the quality of lung collapse with the use of DLT versus BB showed contradicting results and were not conclusive. However, in 2016, Bussières' research group obtained a faster lung collapse with the use of a BB with its internal channel occluded and a second period of apnea at pleural opening.

A review of the literature could not explain in details these results. In the 2000s, lung collapse during OLV was described as undergoing two distinct phases; the first phase occuring at the opening of the pleural cavity and corresponding to a quick but partial collapse secondary to the elastic recoil of the lung. The second phase, a slower one, being the reabsorption, by the vascular capillary bed, of the gas contained into the alveoli; the speed of this second phase being directly proportional to the solubility coefficient of the gas.

Since no previous studies had explanation for Bussières' unexpected results, they conducted a physiologic study to extensively determine the physiology of the non-ventilated lung (NVL) during OLV with the use of DLT and BB. Their results demonstrated that during lung isolation, while the chest is closed, there is a buildup of negative pressure in the NVL until pleural opening, when the lumen of the DLT or the internal channel of the BB are occluded. This phenomenon was observed for both lung isolation devices (BB and DLT). They also observed an absorption of ambient air through the lumen of the DLT and the internal channel of the BB when the lumen of both device was open to ambient air. These results probably explain why Bussières obtained a faster lung collapse with BB in their study. By occluding the internal channel of the BB they prevented the aspiration of ambient air in the NVL. This condition may have accelerated the absorption atelectasis of the NVL that occurs during the second phase of lung collapse by obtaining an initial lower lung volume containing a higher alveolar partial pressure of oxygen (PAO2) in the BB group.

Since these recent findings demonstrate that both lung isolation devices cause negative pressure and an aspiration of ambient air, it is possible that the occlusion of the specific lumen of the NVL of a DLT could reproduce the physiology of the lung isolation obtained with a BB with its internal channel occluded.

The hypothesis is that by withholding gas exchange between the NVL and ambient air from the beginning of OLV to the pleural opening, the resorption atelectasis will be facilitated. Consequently, lung collapse of the NVL will occur faster when clamping its specific lumen on the DLT instead of letting it communicate with ambient air like anesthesiologists usually do.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Just before induction of anesthesia and according to the computerized randomization list generated by the statistical department, each of the 30 patients is allocated to one of the following groups:

Control group : OLV with the specific lumen of the NVL opened to ambient air. Experimental group : OLV with a clamp on the specific lumen of the NVL

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Clamping the Double Lumen Tube : A Novel Technique to Optimize One-Lung Ventilation
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Arm Intervention/treatment
Experimental: Clamping double lumen tube
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
Device: Clamping the Double Lumen Tube
Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation

No Intervention: Not Clamping double lumen tube
Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation



Primary Outcome Measures :
  1. Complete lung collapse (CLC-video) [ Time Frame: From the beginning of surgery (pleural opening) until 60 minutes ]
    A measure of the time required to obtain complete lung collapse (CLC) by a posteriori video evaluation


Secondary Outcome Measures :
  1. Complete lung collapse (CLC-clinical) [ Time Frame: From the beginning of surgery (pleural opening) until 60 minutes ]
    The time required to obtain CLC. This end-point is assessed clinically by the surgeon during the surgery

  2. Quality of lung collapse (video) [ Time Frame: At pleural opening, at 10 and 20 minutes following pleural opening ]
    A posteriori video evaluation,of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3.

  3. Quality of lung collapse (clinical) [ Time Frame: At pleural opening, at 10 and 20 minutes following pleural opening ]
    A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3.

  4. O2 concentration of expired air at pleural opening [ Time Frame: From pleural opening and lasting 60 seconds ]
    A measure of the O2 concentration of the expiratory air at pleural opening

  5. Expiratory volume at pleural opening [ Time Frame: From pleural opening and lasting 60 seconds ]
    A measure of the expiratory volume (EV) at pleural opening

  6. O2 concentration of expired air at the beginning of one-lung ventilation [ Time Frame: From the beginning of one-lung ventilation and lasting 60 seconds ]
    A measure of the O2 concentration of the expiratory air at the beginning of one-lung ventilation (OLV)

  7. Optimization of lung collapse [ Time Frame: From the beginning of surgery (pleural opening) until 60 minutes ]
    Interventions needed to optimize lung collapse during the observation period

  8. Quality of oxygenation during one-lung ventilation (PaO2 ) [ Time Frame: 25 minutes after pleural opening ]
    An evaluation of the PaO2 during one-lung ventilation

  9. Quality of oxygenation during one-lung ventilation (SaO2) [ Time Frame: 25 minutes after pleural opening ]
    An evaluation of the SaO2during one-lung ventilation

  10. Surgery duration [ Time Frame: From the beginning of surgery (pleural opening) until 60 minutes ]
    The time required for completion of the surgery

  11. Postoperative atelectasis [ Time Frame: Postoperative anesthesia care unit (4 hours PO, POD 1, POD 2 and POD 3) ]
    Postoperative X-Ray performed in oder to detect atelectasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective lung resection (lobectomies and segmentectomies) by VATS requiring OLV.
  • More than 18 years old.
  • Having read, understand and signed the consent form presented at the pre-operative evaluation

Exclusion criteria :

A- Pre-operative

  1. Known or anticipated difficult tracheal intubation.
  2. Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.
  3. Severe COPD or asthma (FEV1 <50%).
  4. Prior intrathoracic surgery (including cardiac surgeries).
  5. Pleural or interstitial pathology.
  6. Previous chemotherapy or thoracic radiotherapy.
  7. Acute or chronic pulmonary infection.
  8. Endobronchial mass.
  9. Tracheostomy.

B- Post-randomisation

  1. Bronchoscopic findings contraindicating the insertion of DLT.
  2. VATS findings that cancel the surgery.
  3. Severe desaturation (SatO2 < 90%) during the observation period.
  4. Any need to reinflate the collapse lung.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508050


Locations
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Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec
Quebec City, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Jean Bussières
Investigators
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Principal Investigator: Sabrina Pelletier, MD Laval University
Principal Investigator: Jean S Bussières, MD Laval University

Publications:

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Responsible Party: Jean Bussières, Anesthesiologist, Laval University
ClinicalTrials.gov Identifier: NCT03508050     History of Changes
Other Study ID Numbers: 21436
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No