Mechanical VentilationNCT03704038
Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
A study testing PEEP level in people with Mechanical Ventilation and Bioelectrical Impedance, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation, Bioelectrical Impedance
- What is being tested?
- PEEP level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jun 2018to 1 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
- signed informed consent form
Who cannot join
- preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)
- history of organ transplant
- disseminated malignant disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.
Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.
Read more
Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).
Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.
- Conditions
- Mechanical Ventilation, Bioelectrical Impedance
- Being tested
- PEEP level
- Keywords
- PEEP, Electrical impedance tomography, Mechanical ventialtion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP levelProcedure or surgery
Patients will have variable PEEP levels and will be monitored
| Study group | Role | What they receive |
|---|---|---|
| PEEP 5 | Active comparator | Not described Receives: Procedure: PEEP level |
| PEEP 0 | Active comparator | Not described Receives: Procedure: PEEP level |
| PEEP 10 | Experimental | Not described Receives: Procedure: PEEP level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of nondependent / dependent tidal variation
Measured by EIT
Measured: Baseline, 10 and 90 minutes post lateral positioning
Secondary outcomes (2)
Change of a-A gradient
Measured by ABG analysis
Measured: Baseline, 10 and 90 minutes post lateral positioning
Duration of hospital stay
Between groups
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Jun 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Šribar, University Hospital Dubrava
- Investigators
- Andrej Šribar, MD, PhD, Principal investigator, Anesthesiologist and Critical Care specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704038
- Sponsor's protocol ID
- 2018EIT
- Status last verified
- Apr 2019
- First submitted
- 24 Sep 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography Guided Assessment of Optimum PEEP Levels During Mechanical Ventilation in Lateral Decubitus Position
- ClinicalTrials.gov ID
- NCT03704038
- Acronym / sponsor ID
- 2018EIT
- Conditions
- Mechanical Ventilation, Bioelectrical Impedance
- Keywords
- PEEP, Electrical impedance tomography, Mechanical ventialtion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 12 Oct 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.
Goal of this study is to determine optimal PEEP levels for patients undergoing surgery in lateral decubitus position. Patients will be randomized into 3 groups - PEEP 0, 5 and 10 mbar. Endotracheal anesthesia will be conducted with propofol, fentanyl, rocuronium and sevoflurane/O2/air gas mixture.
Patients with preexisting lung disease, organ transplants and disseminated malignant disease will be excluded.
Demographic data - age, weight, height, ASA status, smoking history will be recorded. EIT measured parameters - tidal variation ratio of nondependent and dependent lung, regional end-tidal and end-expiratory lung impedances as well as horizontal and vertical centers of ventilation will be recorded and calculated at 3 time points - before anesthesia induction, 5 minutes after lateral positioning of the patient and 90 minutes after lateral positioning. ABGs will be sampled to calculate aA gradient and Horovitz quotient at those time points as well as measured hemodynamic parameters (HR, BP, CI, SVI).
Primary endpoints for the study are nondependent/dependent tidal variation ratios measured at predefined time points and changes in ABGs. Secondary endpoints are number of postoperative pulmonary complications (defined as new onset of pneumonia during 28 days of followup), length of hospital stay and changes in hemodynamic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEEP 5 | Active comparator | Procedure: PEEP level |
| PEEP 0 | Active comparator | Procedure: PEEP level |
| PEEP 10 | Experimental | Procedure: PEEP level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for nephrectomy, adrenalectomy or urterotomy surgery which will be performed in lateral decubitus position
- signed informed consent form
Key exclusion criteria (4 listed)
- preexisting moderate to severe obstructive (GOLD score > 1) or restrictive lung disease (FVC < 85%)
- history of organ transplant
- disseminated malignant disease
- pregnancy
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 |
|---|---|---|
| PEEP levelPatients will have variable PEEP levels and will be monitored | Procedure or surgery | PEEP 0, PEEP 10, PEEP 5 |
Primary outcome
Change of nondependent / dependent tidal variation
Time frame: Baseline, 10 and 90 minutes post lateral positioning
Measured by EIT
2 secondary outcomes
Change of a-A gradient
Time frame: Baseline, 10 and 90 minutes post lateral positioning
Duration of hospital stay
Time frame: Up to 28 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 17 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Andrej Šribar, MD, PhD principal investigator
Anesthesiologist and Critical Care specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP level in people with Mechanical Ventilation and Bioelectrical Impedance, run by University Hospital Dubrava at 1 site in Croatia.
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 4 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 17 Apr 2019. 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 Croatia. 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?
Change of nondependent / dependent tidal variation (time frame: Baseline, 10 and 90 minutes post lateral positioning). 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 17 Apr 2019.