Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by London Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01289691
First received: February 1, 2011
Last updated: February 2, 2011
Last verified: February 2011
  Purpose

Patients scheduled for lung lobe resection using video assisted thoracic surgery will be randomly assigned to be ventilated with either only oxygen or a mixture of air and oxygen.

The primary purpose of this study is to determine if the incidence of postoperative collapse (in the non-surgical lung) is decreased when using a mixture of air and oxygen compared to using only oxygen (which is our control measurement) during one-lung ventilation.


Condition Intervention
Pulmonary Atelectasis
Other: One Lung Ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis.

Resource links provided by NLM:


Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:
  • The incidence of postoperative atelectasis [ Time Frame: Immediately after the surgery - up to 2 days post operative. ] [ Designated as safety issue: No ]
    The primary objective is to determine if the incidence of postoperative atelectasis is decreased in the non-surgical lung, during one-lung ventilation (OLV) with mixture of air and oxygen compared to (OLV) using only oxygen (which is our control measurement) .


Secondary Outcome Measures:
  • The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) . [ Time Frame: Intra-operative and Post operative day 1 and 2 . ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Air/Oxygen Mixture
Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
Other: One Lung Ventilation
Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
Other Name: OLV
Active Comparator: Oxygen
Patients in this group will be ventilated with only oxygen during one lung ventilation.
Other: One Lung Ventilation
Patients in this group will be ventilated with only oxygen during one lung ventilation.
Other Name: OLV

Detailed Description:

One of the concerns with all thoracic procedures employing One Lung Ventilation (OLV) is intra-operative hypoxia due to the large shunt that develops when only one lung is being ventilated. Ventilation with a higher fraction of inspired oxygen (FIO2) is one of the commonly chosen strategies for the treatment of hypoxemia during (OLV) for thoracic surgery. Using an FIO2 of 1.0 at all times during (OLV), however, may increase the risk of absorption atelectasis intra and postoperatively which itself leads to persistent hypoxia and potentially pneumonia.

The aim of this study is therefore to determine the impact of adding air to the inspired fraction of oxygen during (OLV) primarily on the incidence of postoperative atelectasis of the nonsurgical lung after lung resection using video assisted thoracic surgery and secondarily on intraoperative and postoperative oxygenation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Competent to give consent to enroll in study
  • Booked for open thoracotomy procedure for lobectomy
  • American Society of Anesthesiologists comorbidity score 1-4

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Pregnant women
  • Inability to insert an arterial line
  • Severe COPD (FEV1 < .7% predicted, or FEV1/FVC < 0.70)
  • Presence of other significant pulmonary impairment (PaO2 on room air 50 mmHg, PaCO2 > 50 mmHg or known pulmonary HTN mean PAP > 25 mmHg)
  • Presence of significant cardiovascular disease (+MIBI that is non-revascularized, CCS ≥ 3 angina, NYHA ≥ 3 CHF, EF (by angiography or echocardiogram < 40%)
  • Chronic renal failure (serum Cr > 200)
  • Altered liver function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289691

Contacts
Contact: Neal Badner, MD, FRCP(C) +1 (519) 685-8500 ext 55115 Neal.Badner@lhsc.on.ca
Contact: Hesham Youssef, M.B.,B.Ch +1 (519) 685-8500 ext 17820 heshanm.youssef@lhsc.on.ca

Locations
Canada, Ontario
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Neal Badner, MD, FRCP(C)    +1 (519) 685-8500 ext 55115    Neal.Badner@lhsc.on.ca   
Contact: Hesham Youssef, M.B.,B.Ch    +1 (519) 685-8500 ext 17820    hesham.youssef@lhsc.on.ca   
Principal Investigator: Neal Badner, MD, FRCP(C)         
Sponsors and Collaborators
London Health Sciences Centre
Investigators
Principal Investigator: Neal Badner, MD, FRCP(C) London Health Science Centre, University Of Western Ontario
  More Information

Publications:
Responsible Party: Neal Badner, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01289691     History of Changes
Other Study ID Numbers: LHSC2010AAPL
Study First Received: February 1, 2011
Last Updated: February 2, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by London Health Sciences Centre:
One Lung Ventilation
Atelectasis
Oxygenation

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014