NCT01289691

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 4, 2011

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

February 1, 2011

Last Update Submit

February 2, 2011

Conditions

Pulmonary Atelectasis

Keywords

One Lung VentilationAtelectasisOxygenation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Intra-operative and Post operative day 1 and 2 .

Study Arms (2)

Air/Oxygen Mixture

EXPERIMENTAL

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

Other: One Lung Ventilation

Oxygen

ACTIVE COMPARATOR

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

Other: One Lung Ventilation

Interventions

One Lung VentilationOTHER

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

Also known as: OLV
Air/Oxygen Mixture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (3)

  • 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.

    PMID: 7717553BACKGROUND

  • 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.

    PMID: 11273912BACKGROUND

  • 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.

    PMID: 7760608BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Officials

  • Neal Badner, MD, FRCP(C)

    London Health Science Centre, University Of Western Ontario

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal Badner, MD, FRCP(C)

CONTACT

+1 (519) 685-8500Neal.Badner@lhsc.on.ca

Hesham Youssef, M.B.,B.Ch

CONTACT

+1 (519) 685-8500heshanm.youssef@lhsc.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 4, 2011

Study Start

July 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 4, 2011

Record last verified: 2011-02

Locations

CA(1)