NCT01495936

Brief Summary

Patients requiring one lung ventilation (OLV) for open thoracic surgery will be ventilated (breathing performed by a breathing machine) during anesthesia using a lung protective ventilation strategy (small breath volumes at 6ml/kg). During thoracic surgery the anesthesiologist is able to ventilate only one lung by inserting a special breathing tube, allowing the surgeon to operate on the non ventilated (diseased) lung. In a randomized trial two interventions used to improve blood oxygen levels during one lung ventilation will be compared . The two interventions are:

  1. 1.Continuous Positive Airway Pressure (CPAP) applied to the non ventilated (non breathing) lung and
  2. 2.Positive End Expiratory Pressure following a lung Recruitment Maneuver (RM-PEEP) to the ventilated (breathing) lung.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 17, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

6.1 years

First QC Date

December 16, 2011

Last Update Submit

November 1, 2017

Conditions

Thoracic, Diseases

Keywords

One Lung Ventilation (OLV)Continuous Positive Airway Pressure (CPAP)Positive End Expiratory Pressure (PEEP)Lung recruitment maneuverHypoxia

Outcome Measures

Primary Outcomes (1)

  • Partial pressure of oxygen in blood

    Time 0 (the patient is anesthetized and being ventilated on two lungs, just prior to the commencement of one lung ventilation). Time 20 minutes (patient has been ventilated on one lung for 20 minutes and immediately prior to instituting one of the two intervention arms). Time 40 minutes (following a period of 20 minutes on one intervention arm \[either CPAP or RM-PEEP\]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm \[either CPAP or RM-PEEP\])

    Day 1

Secondary Outcomes (2)

  • Hypoxia

    Day 1

  • Hypoxia intervention techniques

    Day 1

Study Arms (2)

Continuous Positive Airway Pressure

ACTIVE COMPARATOR

After 20 minutes ventilation on one lung (during anesthesia) the patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-ventilated lung at a pressure of 5cmH20 using the disposable Mallinckrodt Bronchocath CPAP system.

Procedure: Continuous Positive Airway Pressure

RM + Positive End Expiratory Pressure

ACTIVE COMPARATOR

After 20 minutes of ventilation on one lung (during anesthesia) the patient will be randomly assigned to the study arm "RM + Positive End Expiratory pressure" which is a Recruitment Maneuver (RM) followed by Positive End Expiratory Pressure (RM-PEEP) which will be applied to the ventilating lung at a pressure of 5cmH2O.

Procedure: RM + Positive End Expiratory Pressure

Interventions

RM + Positive End Expiratory PressurePROCEDURE

A recruitment maneuver (RM) will be applied to the ventilated lung by performing a valsalva maneuver for 5 seconds (holding the inspiratory pressure at 25cmH2O). Immediately after the RM, Positive End Expiratory Pressure (PEEP) will be applied to the ventilated lung at a pressure of 5cmH2O for 20 minutes. Both the RM and PEEP will be performed using the operating room ventilator.

RM + Positive End Expiratory Pressure
Continuous Positive Airway PressurePROCEDURE

Continuous positive airway pressure, at a pressure of 5cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP)

Continuous Positive Airway Pressure

Eligibility Criteria

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

You may qualify if:

  • Age 18 or older
  • Competent to give consent to enroll in study
  • Booked for scheduled open thoracotomy which involves wedge resection, lobectomy or pneumonectomy requiring OLV
  • American Society of Anesthesia physical status score (ASA) 1-4

You may not qualify if:

  • Unable to give consent
  • Pregnant women
  • Inability to insert an arterial line
  • Presence of other significant pulmonary impairment (PaO2 on room air \<50mmHg, PaCO2 \>50mmHg or known pulmonary hypertension (mean PAP\>25mmHg)
  • Presence of significant cardiovascular disease
  • Altered liver function (Child Pugh scale ≥B)
  • Patients with bullous lung disease. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (12)

  • Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.

    PMID: 19417615BACKGROUND

  • Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24.

    PMID: 19317902BACKGROUND

  • Schilling T, Kozian A, Huth C, Buhling F, Kretzschmar M, Welte T, Hachenberg T. The pulmonary immune effects of mechanical ventilation in patients undergoing thoracic surgery. Anesth Analg. 2005 Oct;101(4):957-965. doi: 10.1213/01.ane.0000172112.02902.77.

    PMID: 16192502BACKGROUND

  • Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007.

    PMID: 16809989BACKGROUND

  • Licker M, de Perrot M, Spiliopoulos A, Robert J, Diaper J, Chevalley C, Tschopp JM. Risk factors for acute lung injury after thoracic surgery for lung cancer. Anesth Analg. 2003 Dec;97(6):1558-1565. doi: 10.1213/01.ANE.0000087799.85495.8A.

    PMID: 14633519BACKGROUND

  • Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. doi: 10.1097/01.anes.0000267607.25011.e8.

    PMID: 17525599BACKGROUND

  • Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9. doi: 10.1097/00000542-200611000-00011.

    PMID: 17065884BACKGROUND

  • Tusman G, Bohm SH, Sipmann FS, Maisch S. Lung recruitment improves the efficiency of ventilation and gas exchange during one-lung ventilation anesthesia. Anesth Analg. 2004 Jun;98(6):1604-1609. doi: 10.1213/01.ANE.0000068484.67655.1A.

    PMID: 15155312BACKGROUND

  • Fan E, Wilcox ME, Brower RG, Stewart TE, Mehta S, Lapinsky SE, Meade MO, Ferguson ND. Recruitment maneuvers for acute lung injury: a systematic review. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1156-63. doi: 10.1164/rccm.200802-335OC. Epub 2008 Sep 5.

    PMID: 18776154BACKGROUND

  • Hoftman N, Canales C, Leduc M, Mahajan A. Positive end expiratory pressure during one-lung ventilation: selecting ideal patients and ventilator settings with the aim of improving arterial oxygenation. Ann Card Anaesth. 2011 Sep-Dec;14(3):183-7. doi: 10.4103/0971-9784.83991.

    PMID: 21860189BACKGROUND

  • Cohen E, Eisenkraft JB, Thys DM, Kirschner PA, Kaplan JA. Oxygenation and hemodynamic changes during one-lung ventilation: effects of CPAP10, PEEP10, and CPAP10/PEEP10. J Cardiothorac Anesth. 1988 Feb;2(1):34-40. doi: 10.1016/0888-6296(88)90145-7.

    PMID: 2979130BACKGROUND

  • Badner NH, Goure C, Bennett KE, Nicolaou G. Role of continuous positive airway pressure to the non-ventilated lung during one-lung ventilation with low tidal volumes. HSR Proc Intensive Care Cardiovasc Anesth. 2011;3(3):189-94.

    PMID: 23439803BACKGROUND

MeSH Terms

Conditions

Thoracic DiseasesHypoxia

Interventions

Positive-Pressure RespirationContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Neal Badner, MD FRCP (C)

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal Badner, MD, FRCP (C)

CONTACT

519 685 8500Neal.Badner@lhsc.on.ca

George Nicolaou, MD, FRCP (C)

CONTACT

519 685 8500George.Nicolaou@lhsc.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

December 20, 2011

Study Start

October 17, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

CA(1)