Clamping the Double Lumen Tube

NCT03508050 | Completed Results

• 1 other identifier: 21436
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

One-lung Ventilation

Outcome Measures

Primary Outcomes (1)

• T50-3

  Moment where the probability of having a complete lung collapse is 50%

  From the beginning of surgery (pleural opening) until 120 minutes

Secondary Outcomes (12)

• Complete Lung Collapse (CLC-clinical)

  From the beginning of surgery (pleural opening) until 60 minutes

• O2 Concentration of Expired Air at Pleural Opening

  From pleural opening and lasting 60 seconds

• Expiratory Volume at Pleural Opening

  From pleural opening and lasting 60 seconds

• O2 Concentration of Expired Air at the Beginning of One-lung Ventilation

  From the beginning of one-lung ventilation and lasting 60 seconds

• Optimization of Lung Collapse

  From the beginning of surgery (pleural opening) until 60 minutes

Study Arms (2)

Clamping double lumen tube

EXPERIMENTAL

Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation

Device: Clamping the Double Lumen Tube

Not Clamping double lumen tube

NO INTERVENTION

Not Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation

Interventions

Clamping the Double Lumen Tube DEVICE

Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation

Clamping double lumen tube

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• A- Pre-operative
• Known or anticipated difficult tracheal intubation.
• Bronchoscopic or CT-scan findings contraindicating the insertion of a DLT.
• Severe COPD or asthma (FEV1 \<50%).
• Prior intrathoracic surgery (including cardiac surgeries).
• Pleural or interstitial pathology.
• Previous chemotherapy or thoracic radiotherapy.
• Acute or chronic pulmonary infection.
• Endobronchial mass.
• Tracheostomy.
• B- Post-randomisation
• Bronchoscopic findings contraindicating the insertion of DLT.
• VATS findings that cancel the surgery.
• Severe desaturation (SatO2 \< 90%) during the observation period.
• Any need to reinflate the collapse lung.

Sponsors & Collaborators

• Jean Bussières: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

Related Publications (8)

• Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2.

  PMID: 25753765 BACKGROUND

• Campos JH, Reasoner DK, Moyers JR. Comparison of a modified double-lumen endotracheal tube with a single-lumen tube with enclosed bronchial blocker. Anesth Analg. 1996 Dec;83(6):1268-72. doi: 10.1097/00000539-199612000-00024.

  PMID: 8942598 BACKGROUND

• Bussieres JS, Somma J, Del Castillo JL, Lemieux J, Conti M, Ugalde PA, Gagne N, Lacasse Y. Bronchial blocker versus left double-lumen endotracheal tube in video-assisted thoracoscopic surgery: a randomized-controlled trial examining time and quality of lung deflation. Can J Anaesth. 2016 Jul;63(7):818-27. doi: 10.1007/s12630-016-0657-3. Epub 2016 May 2.

  PMID: 27138896 BACKGROUND

• Pfitzner J, Peacock MJ, McAleer PT. Gas movement in the nonventilated lung at the onset of single-lung ventilation for video-assisted thoracoscopy. Anaesthesia. 1999 May;54(5):437-43. doi: 10.1046/j.1365-2044.1999.00845.x.

  PMID: 10995140 BACKGROUND

• Joyce CJ, Baker AB, Kennedy RR. Gas uptake from an unventilated area of lung: computer model of absorption atelectasis. J Appl Physiol (1985). 1993 Mar;74(3):1107-16. doi: 10.1152/jappl.1993.74.3.1107.

  PMID: 8482648 BACKGROUND

• Bardoczky GI, Engelman E, d'Hollander A. Continuous spirometry: an aid to monitoring ventilation during operation. Br J Anaesth. 1993 Nov;71(5):747-51. doi: 10.1093/bja/71.5.747.

  PMID: 8251293 BACKGROUND

• Bussieres JS, Slinger P. Correct positioning of double-lumen tubes. Can J Anaesth. 2012 May;59(5):431-6. doi: 10.1007/s12630-012-9689-5. Epub 2012 Mar 7. No abstract available. English, French.

  PMID: 22395826 BACKGROUND

• Somma J, Couture EJ, Pelletier S, Provencher S, Moreault O, Lohser J, Ugalde PA, Vigneault L, Lemieux J, Somma A, Guay SE, Bussieres JS. Non-ventilated lung deflation during one-lung ventilation with a double-lumen endotracheal tube: a randomized-controlled trial of occluding the non-ventilated endobronchial lumen before pleural opening. Can J Anaesth. 2021 Jun;68(6):801-811. doi: 10.1007/s12630-021-01957-9. Epub 2021 Apr 2.

  PMID: 33797018 DERIVED

Limitations and Caveats

Post-randomisation exclusions. Most of them due to negative biopsies cancelling the need of a lobectomy/segmentectomy. The study was single blinded. (the anesthesiologist knew in which group the patient was but the surgeon was blinded)

Results Point of Contact

• Title: Dr Jean S. Bussières
• Organization: Institut universitaire de cardiologie et de pneumologie de Québec

jbuss@criucpq.ulaval.ca

418-656-8711

Study Officials

• Sabrina Pelletier, MD

  Laval University

  PRINCIPAL INVESTIGATOR

• Jean S Bussières, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 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

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: April 25, 2018
• Study Start: September 29, 2017
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: April 27, 2020
• Results First Posted: April 27, 2020

Record last verified: 2020-04

Locations

CA (1)