Recruiting

One-Lung Ventilation

Sponsor:

London Health Sciences Centre

Code:

NCT01289691

Conditions

Pulmonary Atelectasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

One Lung Ventilation

One Lung Ventilation

Study Details

Brief summary:

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.

Conditions

Pulmonary Atelectasis

Study ID

NCT01289691

Start date

Jul, 2010

Status verified date

Feb, 2011

Completion date

Jun, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Air/Oxygen Mixture

Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.

active comparator: Oxygen

Patients in this group will be ventilated with only oxygen during one lung ventilation.

Interventions

One Lung Ventilation

Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.

One Lung Ventilation

Patients in this group will be ventilated with only oxygen during one lung ventilation.

Primary outcome measure

  • The incidence of postoperative atelectasis [ Time Frame: Immediately after the surgery - up to 2 days post operative. ]

Central Contacts and Locations

Central contacts

Neal Badner, MD, FRCP(C)

+1 (519) 685-8500Neal.Badner@lhsc.on.ca

Hesham Youssef, M.B.,B.Ch

+1 (519) 685-8500heshanm.youssef@lhsc.on.ca

Locations

Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Neal Badner, MD, FRCP(C)

+1 (519) 685-8500Neal.Badner@lhsc.on.ca

Hesham Youssef, M.B.,B.Ch

+1 (519) 685-8500hesham.youssef@lhsc.on.ca

Principal Investigator:

Neal Badner, MD, FRCP(C)

More Information

Sponsor

London Health Sciences Centre

Last update posted

Feb 4, 2011

Last verified

Feb, 2011

Keywords

  • One Lung Ventilation
  • Atelectasis
  • Oxygenation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre on 2011-02-04.