HypoxemiaNCT03968120
Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome
A study testing Change of ventilatory settings in people with Hypoxemia and Pulmonary Sepsis, run by University of Debrecen at 1 site in Hungary.
Trial summary
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Pulmonary Sepsis, ARDS, Human
- What is being tested?
- Change of ventilatory settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteHungary
- Study dates
- 1 Feb 2018to 30 Sep 2019
- 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
- Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
- BMI < 35 kg/m2
- Age ≥ 18 years
- Expected duration of surgery > 60 min
- Expected duration of anesthesia > 90 min
Who cannot join
- COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
- uncontrolled asthma
- NYHA 3+4, CCS 3+4
- previous thoracic surgery
- ARDS (Berlin definition)
- documented pulmonary arterial hypertension > 40 mmHg syst
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- documented or suspected neuromuscular disease (thymoma, myasthenia)
- planned mechanical ventilation after surgery
- bilateral procedures
- lung separation with other method than DLT (eg diff. airway, trachestomy)
- surgery in prone position
- persistent hemodynamic instability, intractable shock
- intracranial injury or tumor
- enrollment in other interventional study or refusal of informed consent
- pregnancy (excluded by anamnesis and/or laboratory analysis)
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Debrecen, Department of Anaesthesiology and Intensive Care
Debrecen, 4032
About this study
Official title: Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.
Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs.
Read more
Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults.
The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs.
Patients will be randomly assigned to one of two groups:
FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Read the detailed description
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.
In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
- Conditions
- Hypoxemia, Pulmonary Sepsis, ARDS, Human, Pneumonia
- Being tested
- Change of ventilatory settings
- Medical subject headings
- Hypoxia, Respiratory Distress Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of ventilatory settingsOther
Change of Positive End-Exspiratory Pressure during one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| Group Fix:One-lung ventilation with constant PEEP | No intervention | Controll group: lung protective one-lung ventilation with fix positive end-expiratory pressure (PEEP) |
| Group Variable:One-lung ventilation with variable PEEP | Active comparator | Variable group: lung protective one-lung ventilation with variable positive end-expiratory pressure (PEEP) Receives: Other: Change of ventilatory settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative oxygenation
PaO2 < 60 mmHg
Measured: 1 day
Secondary outcomes (5)
Postoperative pulmonary complications
Infiltrate or atelectasis on chest X-ray, fever, laboratory and physical signs of infection
Measured: 90 days
Postoperative extra-pulmonary complications
new atrial fibrillation, tachycardia, heart failure, myocardial infarct
Measured: 90 days
30 day survival/mortality
number of death within 30 days after surgery
Measured: 30 days
90 day survival/mortality
number of death within 90 days after surgery
Measured: 90 days
Postoperative oxygenation
SpO2/FiO2 ratio
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Feb 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Vegh, MD, University of Debrecen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968120
- Sponsor's protocol ID
- DE RKEB/IKEB 4918-2017
- Status last verified
- Jan 2024
- First submitted
- 14 May 2019
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03968120
- Acronym / sponsor ID
- DE RKEB/IKEB 4918-2017
- Conditions
- Hypoxemia, Pulmonary Sepsis, ARDS, Human, Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 May 2019 (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.
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.
Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs.
Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults.
The investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs.
Patients will be randomly assigned to one of two groups:
FIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers
VARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Detailed description
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.
In GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Fix:One-lung ventilation with constant PEEP | No intervention | –Controll group: lung protective one-lung ventilation with fix positive end-expiratory pressure (PEEP) |
| Group Variable:One-lung ventilation with variable PEEP | Active comparator | Other: Change of ventilatory settingsVariable group: lung protective one-lung ventilation with variable positive end-expiratory pressure (PEEP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
- BMI < 35 kg/m2
- Age ≥ 18 years
- Expected duration of surgery > 60 min
- Expected duration of anesthesia > 90 min
Key exclusion criteria (15 listed)
- COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
- uncontrolled asthma
- NYHA 3+4, CCS 3+4
- previous thoracic surgery
- ARDS (Berlin definition)
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 |
|---|---|---|
| Change of ventilatory settingsChange of Positive End-Exspiratory Pressure during one-lung ventilation | Other | Group Variable:One-lung ventilation with variable PEEP |
Primary outcome
Intraoperative oxygenation
Time frame: 1 day
PaO2 < 60 mmHg
5 secondary outcomes
Postoperative pulmonary complications
Time frame: 90 days
Postoperative extra-pulmonary complications
Time frame: 90 days
30 day survival/mortality
Time frame: 30 days
90 day survival/mortality
Time frame: 90 days
Postoperative oxygenation
Time frame: 90 days
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 5 Jan 2024.
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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.
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 Change of ventilatory settings in people with Hypoxemia and Pulmonary Sepsis, run by University of Debrecen 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 5 inclusion and 15 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 5 Jan 2024. 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?
Intraoperative oxygenation (time frame: 1 day). 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 5 Jan 2024.