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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Atelectasis
• Intervention / Treatment: Other: One Lung Ventilation; Other: One Lung Ventilation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neal Badner, MD, FRCP(C); Phone Number: 55115 +1 (519) 685-8500; Email: Neal.Badner@lhsc.on.ca
• Study Contact Backup: Name: Hesham Youssef, M.B.,B.Ch; Phone Number: 17820 +1 (519) 685-8500; Email: heshanm.youssef@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • Victoria Hospital
      • Contact: Neal Badner, MD, FRCP(C); Phone Number: 55115 +1 (519) 685-8500; Email: Neal.Badner@lhsc.on.ca
      • Contact: Hesham Youssef, M.B.,B.Ch; Phone Number: 17820 +1 (519) 685-8500; Email: hesham.youssef@lhsc.on.ca
      • Principal Investigator: Neal Badner, MD, FRCP(C)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: OLV; Other: One Lung Ventilation; Patients in this group will be ventilated with only oxygen during one lung ventilation.; Other Names: 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 a mixture of air and oxygen during one lung ventilation.; Other Names: OLV; Other: One Lung Ventilation; Patients in this group will be ventilated with only oxygen during one lung ventilation.; Other Names: OLV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative atelectasis	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) .	Immediately after the surgery - up to 2 days post operative.

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .	Intra-operative and Post operative day 1 and 2 .

Collaborators and Investigators

• Sponsor: London Health Sciences Centre
• Investigators: Principal Investigator: Neal Badner, MD, FRCP(C), London Health Science Centre, University of Western Ontario

Publications and helpful links

General Publications

• Rothen HU, Sporre B, Engberg G, Wegenius G, Hogman M, Hedenstierna G. Influence of gas composition on recurrence of atelectasis after a reexpansion maneuver during general anesthesia. Anesthesiology. 1995 Apr;82(4):832-42. doi: 10.1097/00000542-199504000-00004.
• Schwarzkopf K, Klein U, Schreiber T, Preussetaler NP, Bloos F, Helfritsch H, Sauer F, Karzai W. Oxygenation during one-lung ventilation: the effects of inhaled nitric oxide and increasing levels of inspired fraction of oxygen. Anesth Analg. 2001 Apr;92(4):842-7. doi: 10.1097/00000539-200104000-00009.
• Rothen HU, Sporre B, Engberg G, Wegenius G, Reber A, Hedenstierna G. Prevention of atelectasis during general anaesthesia. Lancet. 1995 Jun 3;345(8962):1387-91. doi: 10.1016/s0140-6736(95)92595-3.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2011
• Last Update Submitted That Met QC Criteria: February 2, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: One Lung Ventilation; Atelectasis; Oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: LHSC2010AAPL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No