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

Pulmonary Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01289691
• Other study ID #: LHSC2010AAPL
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2011
• Last updated: February 2, 2011
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: London Health Sciences Centre
• Contact: Neal Badner, MD, FRCP(C)
• Phone: +1 (519) 685-8500
• Email: Neal.Badner[@]lhsc.on.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pulmonary Atelectasis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Rothen HU, Sporre B, Engberg G, Wegenius G, Högman 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .		Intra-operative and Post operative day 1 and 2 .	No