Postoperative Lung InjuryNCT01513018
Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation
A study testing high tidal volumes and low tidal volume in people with Postoperative Lung Injury, run by The Cleveland Clinic at 1 site in Hungary.
Trial summary
The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Lung Injury
- What is being tested?
- high tidal volumes and low tidal volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2009to Sep 2009
- 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
- ASA I-III patients scheduled for lung resection surgery.
Who cannot join
- severe cardiovascular disease
- severe alteration of the preoperative pulmonary function, with FEV1 70-120% predicted and FEV1/FVC ≥ 70% predicted considered to be normal.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Debrecen, Medical and Health Science CenterDepartment of Anesthesiology and Intensive Care
Debrecen, 4032
About this study
The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV.
One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P < 0.05 was considered statistically significant.
- Conditions
- Postoperative Lung Injury
- Being tested
- high tidal volumes, low tidal volume
- Keywords
- OLV, one lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tidal volumesOther
One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition.
Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used.
low tidal volumeOther
One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition.
Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used.
| Study group | Role | What they receive |
|---|---|---|
| high (10 ml/kg) tidal volumes | Active comparator | Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation. Receives: Other: high tidal volumes |
| low tidal volume (5 ml/kg) | Active comparator | Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation. Receives: Other: low tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
low (5ml/kg) tidal volume on arterial oxygenation
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
Measured: 30 minutes of ventillation
high (10 ml/kg) tidal volumes on arterial oxygenation
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
Measured: 30 minutes of ventillation
low (5 ml/kg)tidal volumes on Intrapulmonary shunt
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
Measured: 30 minutes of ventillation
high (10 ml/kg) tidal volumes on Intrapulmonary shunt
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
Measured: 30 minutes of ventillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Lung InjuryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamás Végh, M.D., Principal investigator, Klinikum Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513018
- Sponsor's protocol ID
- DEOEC RKEB/IKEB 2976-2009
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High and Low Tidal Volumes on Arterial Oxygenation and Pulmonary Shunt During One-Lung Ventilation
- ClinicalTrials.gov ID
- NCT01513018
- Acronym / sponsor ID
- DEOEC RKEB/IKEB 2976-2009
- Conditions
- Postoperative Lung Injury
- Keywords
- OLV, one lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Jan 2012 (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.
The ideal tidal volume (TV) during one-lung ventilation (OLV) remains controversial. High tidal volumes may increase the incidence of postoperative lung injury after thoracic surgery. The investigators thus evaluated the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during OLV.
One hundred patients scheduled for thoracic surgery were enrolled. During OLV, patients were randomly assigned to 30 minutes of ventilation with high TV (10 ml/kg with zero end-expiratory pressure (ZEEP)) at a rate of 10 breaths/minute or low tidal volume (5 ml/kg with 5 cm H2O positive end-expiratory pressure (PEEP)) at a rate of 20 breaths/minute. During the subsequent 30 minutes, each patient received the alternative management. Minute volume was thus kept constant during each experimental condition. Arterial blood partial pressures, hemodynamic responses, and ventilatory parameters were recorded. Results are presented as means ± SDs; P < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high (10 ml/kg) tidal volumes | Active comparator | Other: high tidal volumesEvaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation. |
| low tidal volume (5 ml/kg) | Active comparator | Other: low tidal volumeEvaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt 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 (1 listed)
- ASA I-III patients scheduled for lung resection surgery.
Key exclusion criteria (2 listed)
- severe cardiovascular disease
- severe alteration of the preoperative pulmonary function, with FEV1 70-120% predicted and FEV1/FVC ≥ 70% predicted considered to be normal.
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 |
|---|---|---|
| high tidal volumesOne-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition. Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used. | Other | high (10 ml/kg) tidal volumes |
| low tidal volumeOne-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition. Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used. | Other | low tidal volume (5 ml/kg) |
Primary outcome
low (5ml/kg) tidal volume on arterial oxygenation
Time frame: 30 minutes of ventillation
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
high (10 ml/kg) tidal volumes on arterial oxygenation
Time frame: 30 minutes of ventillation
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
low (5 ml/kg)tidal volumes on Intrapulmonary shunt
Time frame: 30 minutes of ventillation
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
high (10 ml/kg) tidal volumes on Intrapulmonary shunt
Time frame: 30 minutes of ventillation
Evaluate the influence of low (5 ml/kg) and high (10 ml/kg) tidal volumes on arterial oxygenation and Intrapulmonary shunt during one lung ventilation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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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.
Tamás Végh, M.D. principal investigator
Klinikum Ludwigshafen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tidal volumes and low tidal volume in people with Postoperative Lung Injury, run by The Cleveland Clinic at 1 site in Hungary.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jan 2012. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
low (5ml/kg) tidal volume on arterial oxygenation (time frame: 30 minutes of ventillation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2012.