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

Primary Purpose

Pulmonary Atelectasis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
One Lung Ventilation
One Lung Ventilation
Sponsored by
London Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Atelectasis focused on measuring One Lung Ventilation, Atelectasis, Oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Victoria HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Air/Oxygen Mixture

Oxygen

Arm Description

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

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

Outcomes

Primary Outcome Measures

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) .

Secondary Outcome Measures

The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .

Full Information

First Posted
February 1, 2011
Last Updated
February 2, 2011
Sponsor
London Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01289691
Brief Title
Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis
Official Title
Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
London Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
One Lung Ventilation, Atelectasis, Oxygenation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Air/Oxygen Mixture
Arm Type
Experimental
Arm Description
Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
Arm Title
Oxygen
Arm Type
Active Comparator
Arm Description
Patients in this group will be ventilated with only oxygen during one lung ventilation.
Intervention Type
Other
Intervention Name(s)
One Lung Ventilation
Other Intervention Name(s)
OLV
Intervention Description
Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
Intervention Type
Other
Intervention Name(s)
One Lung Ventilation
Other Intervention Name(s)
OLV
Intervention Description
Patients in this group will be ventilated with only oxygen during one lung ventilation.
Primary Outcome Measure Information:
Title
The incidence of postoperative atelectasis
Description
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) .
Time Frame
Immediately after the surgery - up to 2 days post operative.
Secondary Outcome Measure Information:
Title
The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .
Time Frame
Intra-operative and Post operative day 1 and 2 .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neal Badner, MD, FRCP(C)
Phone
+1 (519) 685-8500
Ext
55115
Email
Neal.Badner@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Hesham Youssef, M.B.,B.Ch
Phone
+1 (519) 685-8500
Ext
17820
Email
heshanm.youssef@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Badner, MD, FRCP(C)
Organizational Affiliation
London Health Science Centre, University Of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Badner, MD, FRCP(C)
Phone
+1 (519) 685-8500
Ext
55115
Email
Neal.Badner@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Hesham Youssef, M.B.,B.Ch
Phone
+1 (519) 685-8500
Ext
17820
Email
hesham.youssef@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Neal Badner, MD, FRCP(C)

12. IPD Sharing Statement

Citations:
PubMed Identifier
7717553
Citation
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.
Results Reference
background
PubMed Identifier
11273912
Citation
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.
Results Reference
background
PubMed Identifier
7760608
Citation
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.
Results Reference
background

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

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