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

NCT ID: NCT01289691

Last Updated: 2011-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Pulmonary Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Air/Oxygen Mixture

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

Group Type EXPERIMENTAL

One Lung Ventilation

Intervention Type OTHER

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

Oxygen

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

Group Type ACTIVE_COMPARATOR

One Lung Ventilation

Intervention Type OTHER

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

Interventions

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One Lung Ventilation

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

Intervention Type OTHER

One Lung Ventilation

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

Intervention Type OTHER

Other Intervention Names

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OLV OLV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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London Health Sciences Centre

Principal Investigators

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Neal Badner, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

London Health Science Centre, University Of Western Ontario

Locations

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Victoria Hospital

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Neal Badner, MD, FRCP(C)

Role: CONTACT

+1 (519) 685-8500 ext. 55115

Hesham Youssef, M.B.,B.Ch

Role: CONTACT

+1 (519) 685-8500 ext. 17820

Facility Contacts

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Neal Badner, MD, FRCP(C)

Role: primary

+1 (519) 685-8500 ext. 55115

Hesham Youssef, M.B.,B.Ch

Role: backup

+1 (519) 685-8500 ext. 17820

References

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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.

Reference Type BACKGROUND
PMID: 7717553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11273912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7760608 (View on PubMed)

Other Identifiers

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LHSC2010AAPL

Identifier Type: -

Identifier Source: org_study_id

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