Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis
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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. |
- 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) .
- 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 |
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| 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 |
| 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) | |
| 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 May 23, 2013