One Lung VentilationNCT03563612
Differential Lung Ventilation vs. CPAP
A study testing cpap in people with One Lung Ventilation and Continuous Positive Airway Pressure, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- One Lung Ventilation, Continuous Positive Airway Pressure, Differential Lung Ventilation
- What is being tested?
- cpap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2017to 30 Sep 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnised with lung cancer
- Scheduled to have thoracoscopic lung lobectomy -
Who cannot join
- Pregnancy
- ASA>=4
- Difficult intubation -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Lung Ventilation vs. CPAP During One Lung Ventilation for Video Assisted Lung Surgery
In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection.
Read the detailed description
Background: One Lung Ventilation (OLV) is the technique used during lung resection surgery in order to facilitate optimal surgical conditions. OLV may result in hypoxemia due to the shunt created. Several techniques are used to overcome the hypoxemia, one of which is continuous positive airway pressure (CPAP) to the non-dependent lung. Another technique is ventilating the non-dependent lung with a minimal volume, thus creating differential lung ventilation (DLV). In this study we compared the efficacy of CPAP to DLV during video assisted thoracoscopic lung resection.
Patients and Method: This is a prospective study of 30 adult patients undergoing elective video assisted thoracoscopic lung lobectomy. Each patient was ventilated in four modes: two lung ventilation, OLV, OLV+CPAP and OLV+DLV. Fifteen patients were ventilated with CPAP first and DLV next, and the other 15 were ventilated with DLV first and then CPAP. Five minutes separated each mode, during which the non-dependent lung was open to room air. We measured the patient's arterial blood gas during each mode of ventilation. The surgeons, who were blinded to the ventilation technique, were asked to assess the surgical conditions at each stage.
- Being tested
- cpap
- Keywords
- one lung ventilation, continuous positive airway pressure, differential lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cpapDevice
application of cpap to the non-dependent lung, during one lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| cpap first, differential ventilation later | Active comparator | Not described Receives: Device: cpap |
| differential ventilation first, cpap late | Active comparator | Not described Receives: Device: cpap |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood oxygenation
PaO2
Measured: intraoperative
Secondary outcomes (2)
interference with surgical field exposure
interference
Measured: intraoperative
airway pressure in the dependent lung during one lung ventilation
airway pressure
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for One Lung VentilationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomized controlled crossover study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Michal Barak, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563612
- Sponsor's protocol ID
- RMB-0032-16
- Status last verified
- Jun 2018
- First submitted
- 26 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kremer R, Aboud W, Haberfeld O, Armali M, Barak M. Differential lung ventilation for increased oxygenation during one lung ventilation for video assisted lung surgery. J Cardiothorac Surg. 2019 May 6;14(1):89. doi: 10.1186/s13019-019-0910-2.
PubMed 31060627
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Lung Ventilation vs. CPAP During One Lung Ventilation for Video Assisted Lung Surgery
- ClinicalTrials.gov ID
- NCT03563612
- Acronym / sponsor ID
- RMB-0032-16
- Keywords
- one lung ventilation, continuous positive airway pressure, differential lung ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 20 Jun 2018 (actual)
- 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.
In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection.
Detailed description
Background: One Lung Ventilation (OLV) is the technique used during lung resection surgery in order to facilitate optimal surgical conditions. OLV may result in hypoxemia due to the shunt created. Several techniques are used to overcome the hypoxemia, one of which is continuous positive airway pressure (CPAP) to the non-dependent lung. Another technique is ventilating the non-dependent lung with a minimal volume, thus creating differential lung ventilation (DLV). In this study we compared the efficacy of CPAP to DLV during video assisted thoracoscopic lung resection.
Patients and Method: This is a prospective study of 30 adult patients undergoing elective video assisted thoracoscopic lung lobectomy. Each patient was ventilated in four modes: two lung ventilation, OLV, OLV+CPAP and OLV+DLV. Fifteen patients were ventilated with CPAP first and DLV next, and the other 15 were ventilated with DLV first and then CPAP. Five minutes separated each mode, during which the non-dependent lung was open to room air. We measured the patient's arterial blood gas during each mode of ventilation. The surgeons, who were blinded to the ventilation technique, were asked to assess the surgical conditions at each stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| cpap first, differential ventilation later | Active comparator | Device: cpap |
| differential ventilation first, cpap late | Active comparator | Device: cpap |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients diagnised with lung cancer
- Scheduled to have thoracoscopic lung lobectomy -
Key exclusion criteria (3 listed)
- Pregnancy
- ASA>=4
- Difficult intubation -
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 |
|---|---|---|
| cpapapplication of cpap to the non-dependent lung, during one lung ventilation | Device | cpap first, differential ventilation later, differential ventilation first, cpap late |
Primary outcome
arterial blood oxygenation
Time frame: intraoperative
PaO2
2 secondary outcomes
interference with surgical field exposure
Time frame: intraoperative
airway pressure in the dependent lung during one lung ventilation
Time frame: intraoperative
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 Jun 2018.
- Derived from this study: PubMed 31060627Kremer R, Aboud W, Haberfeld O, Armali M, Barak M. Differential lung ventilation for increased oxygenation during one lung ventilation for video assisted lung surgery. J Cardiothorac Surg. 2019 May 6;14(1):89. doi: 10.1186/s13019-019-0910-2.
Related trials for One Lung Ventilation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Not yet recruiting
Video-guided Versus Conventional Right-sided Double-lumen Tube Placement for Thoracoscopic Surgery
Right-sided Double-lumen Tube Positioning, Lung Isolation During Thoracoscopic Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cpap in people with One Lung Ventilation and Continuous Positive Airway Pressure, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 3 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 Jun 2018. 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 Israel. 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?
arterial blood oxygenation (time frame: intraoperative). 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 NCT03563612, which also lists 1 linked publication.
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 Jun 2018.