Pulmonary AtelectasisNCT01289691
Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis
A study testing One Lung Ventilation in people with Pulmonary Atelectasis, run by London Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- One Lung Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital
London, Ontario, N6A 5W9
Neal Badner, MD, FRCP(C), +1 (519) 685-8500 ext. 55115, Neal.Badner@lhsc.on.ca
Hesham Youssef, M.B.,B.Ch, +1 (519) 685-8500 ext. 17820, hesham.youssef@lhsc.on.ca
About this study
Official title: Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis.
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.
Read the 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.
- Conditions
- Pulmonary Atelectasis
- Being tested
- One Lung Ventilation
- Keywords
- One Lung Ventilation, Atelectasis, Oxygenation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Lung VentilationOther
Also called OLV
Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
One Lung VentilationOther
Also called OLV
Patients in this group will be ventilated with only oxygen during one lung ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Air/Oxygen Mixture | Experimental | Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation. Receives: Other: One Lung Ventilation |
| Oxygen | Active comparator | Patients in this group will be ventilated with only oxygen during one lung ventilation. Receives: Other: One Lung Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: Immediately after the surgery - up to 2 days post operative.
Secondary outcomes (1)
The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .
Measured: Intra-operative and Post operative day 1 and 2 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Neal Badner, MD, FRCP(C), Principal investigator, London Health Science Centre, University Of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289691
- Sponsor's protocol ID
- LHSC2010AAPL
- Status last verified
- Feb 2011
- First submitted
- 1 Feb 2011
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7717553Schwarzkopf 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.
PubMed 11273912Rothen 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.
PubMed 7760608
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atelectasis After Pulmonary Lobectomy: The Effect Of Air During One-Lung Ventilation (OLV) On Postoperative Atelectasis.
- ClinicalTrials.gov ID
- NCT01289691
- Acronym / sponsor ID
- LHSC2010AAPL
- Conditions
- Pulmonary Atelectasis
- Keywords
- One Lung Ventilation, Atelectasis, Oxygenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air/Oxygen Mixture | Experimental | Other: One Lung VentilationPatients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation. |
| Oxygen | Active comparator | Other: One Lung VentilationPatients in this group will be ventilated with only oxygen during one lung ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Lung VentilationAlso: OLVPatients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation. | Other | Air/Oxygen Mixture |
| One Lung VentilationAlso: OLVPatients in this group will be ventilated with only oxygen during one lung ventilation. | Other | Oxygen |
Primary outcome
The incidence of postoperative atelectasis
Time frame: Immediately after the surgery - up to 2 days post operative.
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) .
1 secondary outcome
The incidence of intraoperative and postoperative hypoxia (SpO2 < 90%) .
Time frame: Intra-operative and Post operative day 1 and 2 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2011.
- Background: PubMed 7717553Rothen 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.
- Background: PubMed 11273912Schwarzkopf 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.
- Background: PubMed 7760608Rothen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Badner, MD, FRCP(C) principal investigator
London Health Science Centre, University Of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Lung Ventilation in people with Pulmonary Atelectasis, run by London Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neal Badner, MD, FRCP(C) (+1 (519) 685-8500 ext. 55115, Neal.Badner@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative atelectasis (time frame: Immediately after the surgery - up to 2 days post operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289691, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2011.