Clinical trial NCT01289691: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Atelectasis
Keywords: One Lung Ventilation
Atelectasis
Oxygenation
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The incidence of postoperative atelectasis
timeFrame: Immediately after the surgery - up to 2 days post operative.
Secondary outcomes:
measure: The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .
timeFrame: Intra-operative and Post operative day 1 and 2 .
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: London Health Science Centre, University Of Western Ontario
name: Neal Badner, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.