NCT02919267

Brief Summary

Lung isolation technique and one-lung ventilation (OLV) are the mainstays of thoracic anesthesia. Two principal lung isolation techniques are mainly use by clinicians, the double lumen tubes (DLT) and the bronchial blockers (BB). The physiology of lung collapse during OLV is not well described in the literature. Few publications characterized scant aspects of lung collapse, only with the use of DLT and sometime in experimental animals. Two phases of lung collapse have been described. The first phase is a quick and partial secondary to the intrinsic recoil of the lung. The second phase is the reabsorption of gas contained in the alveoli by the capillary bed. The investigators plan to describe the physiology of the second phase of lung deflation using of DLT or BB, in a human clinical context.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 22, 2019

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

September 28, 2016

Results QC Date

January 7, 2019

Last Update Submit

May 11, 2020

Conditions

Keywords

One lung ventilationLung collapseBronchial blockerDouble lumen tubevideo assisted thoracoscopic surgeryVATSDLTThoracic surgeryVideo-assisted

Outcome Measures

Primary Outcomes (1)

  • Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.

    From the beginning of OLV until 60 minutes

Secondary Outcomes (1)

  • Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB

    From the beginning until 10 minutes of OLV

Study Arms (2)

Intra-pulmonary pressure determination

OTHER

A pressure tubing catheter will be connected to the luerlock adaptor of the bronchial blocker (BB) or to the adaptor located on the side of the occluding system mounted at the extremity of the double lumen tube (DLT). The catheter will then be connected to a differential pressure transducer (AD Instruments, Colorado Springs, CO, USA), allowing direct visualisation of the bronchial pressures. Along with intra-bronchial pressure, esophageal pressure will also be measured to eliminate the pressure generated by the positive pressure of the ventilated lung (Adult esophageal balloon catheter, Cooper Surgical, Trumbull, CT, USA). Intra-bronchial pressures will be measured at end-inspiration and end-expiration.

Device: Double lumen tubeDevice: Bronchial blocker

Volume determination

OTHER

A one-liter bag (Roxon, Etobicoke, ON, Canada) will be filled precisely with 300 mL of air with the use of a calibrated syringe of 3 liters (Hans Rudolph inc, Shawnee, Kansas, United States), through a three-way valve (Hans Rudolph inc, Shawnee, Kansas, United States). Following the filling of the bag, it will be connected to the non-ventilated lumen of the double lumen tube (DLT) or to the bronchial blocker (BB) through the three-way connector. At the end of the observation period, the collector bag will be connected to the calibrated syringe and will emptied from its residual volume.

Device: Double lumen tubeDevice: Bronchial blocker

Interventions

Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the L-DLT group.

Also known as: Left-sided double lumen tube (BronchoCath, Mallinkrodt)
Intra-pulmonary pressure determinationVolume determination

Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the BB group.

Also known as: Bronchial blocker (Fuji Uniblocker, Fuji Systems)
Intra-pulmonary pressure determinationVolume determination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective unilateral lung resection (anatomical segmentectomy, lobectomy or pneumonectomy) for lung cancer

You may not qualify if:

  • anticipated difficult mask ventilation or intubation
  • pleural pathology
  • previous thoracic surgery
  • previous sternotomy
  • previous chemotherapy or chest radiotherapy
  • severe COPD or asthma (FEV1 ≤ 50%)
  • active or chronic pulmonary infection
  • endobronchial mass
  • tracheostomy
  • severe desaturation before or during the observation period
  • any clinical situation precluding the use of one of the lung isolation device
  • air leak at the level of bronchial isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Canada

Location

Related Publications (19)

  • Shah RD, D'Amico TA. Modern impact of video assisted thoracic surgery. J Thorac Dis. 2014 Oct;6(Suppl 6):S631-6. doi: 10.3978/j.issn.2072-1439.2014.08.02.

    PMID: 25379201BACKGROUND
  • 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: 8482648BACKGROUND
  • 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: 10995140BACKGROUND
  • Pfitzner J, Peacock MJ, Harris RJ. Speed of collapse of the non-ventilated lung during single-lung ventilation for thoracoscopic surgery: the effect of transient increases in pleural pressure on the venting of gas from the non-ventilated lung. Anaesthesia. 2001 Oct;56(10):940-6. doi: 10.1046/j.1365-2044.2001.02211.x.

    PMID: 11576095BACKGROUND
  • 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: 8942598BACKGROUND
  • Bauer C, Winter C, Hentz JG, Ducrocq X, Steib A, Dupeyron JP. Bronchial blocker compared to double-lumen tube for one-lung ventilation during thoracoscopy. Acta Anaesthesiol Scand. 2001 Feb;45(2):250-4.

    PMID: 11167173BACKGROUND
  • Campos JH, Kernstine KH. A comparison of a left-sided Broncho-Cath with the torque control blocker univent and the wire-guided blocker. Anesth Analg. 2003 Jan;96(1):283-9, table of contents. doi: 10.1097/00000539-200301000-00056.

    PMID: 12505967BACKGROUND
  • Dumans-Nizard V, Liu N, Laloe PA, Fischler M. A comparison of the deflecting-tip bronchial blocker with a wire-guided blocker or left-sided double-lumen tube. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):501-5. doi: 10.1053/j.jvca.2009.02.002. Epub 2009 Apr 10.

    PMID: 19362014BACKGROUND
  • 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: 25753765BACKGROUND
  • 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: 27138896BACKGROUND
  • Merchant R, Chartrand D, Dain S, Dobson J, Kurrek M, LeDez K, Morgan P, Shukla R; Canadian Anesthesiologists' Society. Guidelines to the Practice of Anesthesia Revised Edition 2012. Can J Anaesth. 2012 Jan;59(1):63-102. doi: 10.1007/s12630-011-9609-0. English, French.

    PMID: 22183296BACKGROUND
  • Brodsky JB, Lemmens HJ. Tracheal width and left double-lumen tube size: a formula to estimate left-bronchial width. J Clin Anesth. 2005 Jun;17(4):267-70. doi: 10.1016/j.jclinane.2004.07.008.

    PMID: 15950850BACKGROUND
  • Fortier G, Cote D, Bergeron C, Bussieres JS. New landmarks improve the positioning of the left Broncho-Cath double-lumen tube-comparison with the classic technique. Can J Anaesth. 2001 Sep;48(8):790-4. doi: 10.1007/BF03016696.

    PMID: 11546721BACKGROUND
  • Kovacs G, Avian A, Olschewski A, Olschewski H. Zero reference level for right heart catheterisation. Eur Respir J. 2013 Dec;42(6):1586-94. doi: 10.1183/09031936.00050713. Epub 2013 Jun 21.

    PMID: 23794468BACKGROUND
  • Joyce CJ, Baker AB, Parkinson R, Zacharias M. Nitrous oxide and the rate of gas uptake from an unventilated lung in dogs. Br J Anaesth. 1996 Feb;76(2):292-6. doi: 10.1093/bja/76.2.292.

    PMID: 8777113BACKGROUND
  • Pfitzner J, Peacock MJ, Pfitzner L. Speed of collapse of the non-ventilated lung during one-lung anaesthesia: the effects of the use of nitrous oxide in sheep. Anaesthesia. 2001 Oct;56(10):933-9. doi: 10.1046/j.1365-2044.2001.02210.x.

    PMID: 11576094BACKGROUND
  • Ko R, McRae K, Darling G, Waddell TK, McGlade D, Cheung K, Katz J, Slinger P. The use of air in the inspired gas mixture during two-lung ventilation delays lung collapse during one-lung ventilation. Anesth Analg. 2009 Apr;108(4):1092-6. doi: 10.1213/ane.0b013e318195415f.

    PMID: 19299766BACKGROUND
  • Yoshimura T, Ueda K, Kakinuma A, Sawai J, Nakata Y. Bronchial blocker lung collapse technique: nitrous oxide for facilitating lung collapse during one-lung ventilation with a bronchial blocker. Anesth Analg. 2014 Mar;118(3):666-70. doi: 10.1213/ANE.0000000000000106.

    PMID: 24557112BACKGROUND
  • Moreault O, Couture EJ, Provencher S, Somma J, Lohser J, Ugalde PA, Lemieux J, Lellouche F, Bussieres JS. Double-lumen endotracheal tubes and bronchial blockers exhibit similar lung collapse physiology during lung isolation. Can J Anaesth. 2021 Jun;68(6):791-800. doi: 10.1007/s12630-021-01938-y. Epub 2021 Feb 16.

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr Jean Bussières
Organization
Institut universitaire de cardiologie de de pneumologie de Québec

Study Officials

  • Olivier Moreault, 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
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

September 28, 2016

First Posted

September 29, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 26, 2020

Results First Posted

July 22, 2019

Record last verified: 2020-05

Locations