AtelectasisoptiPEEPNCT04900714
Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position
A study testing Decremental PEEP, Lung ultrasound score and Blood gas analysis in people with Atelectasis, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The investigators hypothesize that the level of PEEP is often suboptimally applied in certain operative conditions, such as in laparoscopy with head down (Trendelenburg) positioning. This can result in excessive levels of lung stress and postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- Decremental PEEP, Lung ultrasound score and Blood gas analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jun 2021to 23 Sep 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective laparoscopy in the Trendelenburg (head-down) position
Who cannot join
- smoker
- lung disease (e.g. asthma, COPD, emphysema)
- BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that the level of PEEP is often suboptimally applied in certain operative conditions, such as in laparoscopy with head down (Trendelenburg) positioning. This can result in excessive levels of lung stress and postoperative pulmonary complications.
In patients with steep Trendelenburg and a pneumoperitoneum, the investigators aim to
- measure apical versus basal atelectasis using the lung ultrasound score
- compare lung ultrasound scores at different PEEP levels
- compare respiratory mechanics at the different PEEP levels
- contrast the optimal PEEP level to standard practice
- provide guidance to optimal PEEP titration in this setting for the clinician
Read the detailed description
The investigators hypothesize that the level of positive end-expiratory pressure (PEEP) is often incorrectly applied in certain operative conditions, such as in laparoscopy with head down (Trendelenburg) positioning. This can result in excessive levels of lung stress and postoperative pulmonary complications.
Incorrect intra-operative ventilator management can be harmful for the patient, potentially leading to postoperative pulmonary complications and ventilator-induced lung injury. During routine anesthesia procedures, most anesthetists will set the ventilator by rule of thumb with a PEEP of 4-6 cmH2O, a tidal volume of 6-8 ml/kg of ideal body weight and a frequency of 10-15 breaths per minute in order to provide lung protective ventilation. However, due to recent advances in surgical practice, patients are more frequently placed in non- physiological states, such as Trendelenburg position up to 30° with concurrent pneumoperitoneum and intra-abdominal pressures of 15mmHg or higher, as in for example robot-assisted radical prostatectomy or gynecological procedures. This extreme positioning and increased intra-abdominal pressure can have a significant effect on respiratory mechanics and can potentially result in excessive lung stress. The changes in applied positive pressure ventilation will result in changes of regional ventilation: both an increased amount of atelectasis and an increased amount of regional hyperinflation are observed in this setting. The ideal PEEP level balances the recruitment of atelectasis versus excessive hyperinflation. These changes in regional ventilation can be assessed by lung ultrasound. The lung ultrasound score can distinguish atelectasis from normal aeration in the different lung regions of interest.
This project is designed as a single center cohort study. Non-obese (BMI < 30kg/m2), lung-healthy non-pregnant, non-smoking individuals without right sided heart failure, scheduled for elective laparoscopy of the lower abdomen, will be recruited. Standardized induction and maintenance with propofol TCI (3-6μg/l plasma concentration as calculated by the Marsh model), sufentanil (0.2μg/kg) and rocuronium (0.6mg/kg) will be provided. Neuromuscular blockade will be monitored using a train-of-four (TOF) monitor and kept with a TOF count < 1 throughout the study using additional doses if indicated. A radial arterial line will be placed. Mechanical ventilation will be provided in volume control mode with a tidal volume of 4-6 ml/kg of ideal body weight (IBW) aiming for a driving pressure ≤ 15cmH2O, a starting PEEP of 5cmH2O, a frequency of 12-18 breaths per minute titrated to the end-tidal CO2 measurement and an initial FiO2 of 0.4. An esophageal balloon catheter with pressure sensor will be used to calculate transpulmonary pressures. The balloon and pressure sensor will be calibrated as per manufacturers guideline. Respiratory parameters will be recorded and saved for later evaluation using the FluxMed GrT monitor and software (MBMED, Argentina). After inflation of the pneumoperitoneum, lung ultrasound will be performed bilaterally at the midclavicular line between the second and third ribs, at the posterior axillary line above the level of T4 and at the posterior axillary line closely superior to the diaphragm, thus retaining 6 ultrasound loops which will be saved for post-hoc lung ultrasound scoring. The lung ultrasound measurements will be repeated at different decremental levels of PEEP: 15, 10, 5 and 0 cmH2O respectively. Arterial blood gas analysis will be performed before insufflation of the pneumoperitoneum and repeated at each level of PEEP. A minimum of 4 minutes equilibration time will be provided after changing PEEP.
- Conditions
- Atelectasis
- Being tested
- Decremental PEEP, Lung ultrasound score, Blood gas analysis, Registration of respiratory mechanics, Evaluation of dead space
- Keywords
- Positive-Pressure Respiration, Respiratory Mechanics, positive end-expiratory pressure
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decremental PEEPProcedure or surgery
High PEEP to low PEEP.
Lung ultrasound scoreDiagnostic test
lung ultrasound to determine the extend of atelectasis. Uses validated lung ultrasound score.
Blood gas analysisDiagnostic test
Blood gas analysis to determine arterial oxygen tension
Registration of respiratory mechanicsDiagnostic test
Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)
Evaluation of dead spaceDiagnostic test
Dead space will be measured non-invasively using volumetric capnography on the FluxMed respiratory monitor (MBMED, Argentina)
| Study group | Role | What they receive |
|---|---|---|
| Decremental PEEP | Experimental | Every participant will be exposed to a stepwise decremental PEEP. Receives: Procedure: Decremental PEEP; Diagnostic Test: Lung ultrasound score; Diagnostic Test: Blood gas analysis; Diagnostic Test: Registration of respiratory mechanics; Diagnostic Test: Evaluation of dead space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound score
Lung ultrasound score per level of PEEP (15-10-5-0 cmH2O). The score is dimensionless. A cumulative count is calculated for each level of PEEP by adding the scores from the 6 scanned lung regions together.
The lung ultrasound score is a measure of atelectasis.
Measured: Perioperatively
Secondary outcomes (5)
Transpulmonary pressure (cmH2O)
Transpulmonary pressure per level of PEEP (15-10-5-0 cmH2O). Transpulmonary pressure is calculated as plateau airway pressure minus esophageal pressure (at the same timepoint).
Plateau airway pressures (cmH2O) are measured at the ventilator during an inspiratory pause.
Esophageal pressures (cmH2O) are measured with an esophageal balloon and pressure transducer.
Esophageal pressures are proven to correlate closely to pleural pressures. The Fluxmed device (MBMED, Argentina) is used to capture pressures and volumes at the ventilator.
Measured: Perioperatively
Driving pressure (cmH2O)
Driving pressures per level of PEEP (15-10-5-0 cmH2O). Driving pressure (cmH2O) is calculated as plateau airway pressure minus positive end-expiratory pressure (PEEP).
Plateau airway pressures (cmH2O) are measured at the ventilator during an inspiratory pause.
PEEP (cmH2O) is measured at the ventilator at end-expiration. The Fluxmed device (MBMED, Argentina) is used to capture pressures and volumes at the ventilator.
Measured: Perioperatively
Dynamic pulmonary compliance (ml/cmH2O)
Dynamic pulmonary compliance per level of PEEP (15-10-5-0 cmH2O). The dynamic pulmonary compliance is calculated as tidal volume divided by the driving pressure.
Tidal volumes (ml) are measured at the ventilator. Driving pressures are calculated as mentioned in the description of outcome 3. The Fluxmed device (MBMED, Argentina) is used to capture pressures and volumes at the ventilator.
Measured: Perioperatively
P/F ratio (Horowitz index, mmHg / %)
Ratio of the arterial oxygen tension (mmHg) divided by the fraction of inspired oxygen (%) per level of PEEP (15-10-5-0 cmH2O).
The arterial oxygen tension is measured at a point-of-care blood gas analyzer (Roche Cobas, Basel, Swiss) The inspiratory oxygen fraction (%) is measured at the ventilator.
Measured: Perioperatively
Dead space
Median dead space per level of PEEP (15-10-5-0 cmH2O).
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start21 Jun 2021
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
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 AtelectasisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Saldien, MD, PhD, Principal investigator, Head of the department of anesthesiologyTom Schepens, MD, PhD, Study chair, Anesthetist/intensivistGregory De Meyer, MD, Study chair, Anesthetist in trainingStuart G Morrison, MD, Study director, Staff anesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900714
- Sponsor's protocol ID
- 20/40/516
- Other IDs
- 1378, 20/40/516
- Acronym
- optiPEEP
- Status last verified
- Jan 2022
- First submitted
- 24 Sep 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Meyer GRA, Morrison SG, Saldien V, Jorens PG, Schepens T. Minimizing Lung Injury During Laparoscopy in Head-Down Tilt: A Physiological Cohort Study. Anesth Analg. 2023 Oct 1;137(4):841-849. doi: 10.1213/ANE.0000000000006325. Epub 2022 Dec 14.
PubMed 36729514
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position
- ClinicalTrials.gov ID
- NCT04900714
- Acronym / sponsor ID
- optiPEEP / 20/40/516
- Conditions
- Atelectasis
- Keywords
- Positive-Pressure Respiration, Respiratory Mechanics, positive end-expiratory pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 25 May 2021 (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.
The investigators hypothesize that the level of PEEP is often suboptimally applied in certain operative conditions, such as in laparoscopy with head down (Trendelenburg) positioning. This can result in excessive levels of lung stress and postoperative pulmonary complications.
In patients with steep Trendelenburg and a pneumoperitoneum, the investigators aim to
- measure apical versus basal atelectasis using the lung ultrasound score
- compare lung ultrasound scores at different PEEP levels
- compare respiratory mechanics at the different PEEP levels
- contrast the optimal PEEP level to standard practice
- provide guidance to optimal PEEP titration in this setting for the clinician
Detailed description
The investigators hypothesize that the level of positive end-expiratory pressure (PEEP) is often incorrectly applied in certain operative conditions, such as in laparoscopy with head down (Trendelenburg) positioning. This can result in excessive levels of lung stress and postoperative pulmonary complications.
Incorrect intra-operative ventilator management can be harmful for the patient, potentially leading to postoperative pulmonary complications and ventilator-induced lung injury. During routine anesthesia procedures, most anesthetists will set the ventilator by rule of thumb with a PEEP of 4-6 cmH2O, a tidal volume of 6-8 ml/kg of ideal body weight and a frequency of 10-15 breaths per minute in order to provide lung protective ventilation. However, due to recent advances in surgical practice, patients are more frequently placed in non- physiological states, such as Trendelenburg position up to 30° with concurrent pneumoperitoneum and intra-abdominal pressures of 15mmHg or higher, as in for example robot-assisted radical prostatectomy or gynecological procedures. This extreme positioning and increased intra-abdominal pressure can have a significant effect on respiratory mechanics and can potentially result in excessive lung stress. The changes in applied positive pressure ventilation will result in changes of regional ventilation: both an increased amount of atelectasis and an increased amount of regional hyperinflation are observed in this setting. The ideal PEEP level balances the recruitment of atelectasis versus excessive hyperinflation. These changes in regional ventilation can be assessed by lung ultrasound. The lung ultrasound score can distinguish atelectasis from normal aeration in the different lung regions of interest.
This project is designed as a single center cohort study. Non-obese (BMI < 30kg/m2), lung-healthy non-pregnant, non-smoking individuals without right sided heart failure, scheduled for elective laparoscopy of the lower abdomen, will be recruited. Standardized induction and maintenance with propofol TCI (3-6μg/l plasma concentration as calculated by the Marsh model), sufentanil (0.2μg/kg) and rocuronium (0.6mg/kg) will be provided. Neuromuscular blockade will be monitored using a train-of-four (TOF) monitor and kept with a TOF count < 1 throughout the study using additional doses if indicated. A radial arterial line will be placed. Mechanical ventilation will be provided in volume control mode with a tidal volume of 4-6 ml/kg of ideal body weight (IBW) aiming for a driving pressure ≤ 15cmH2O, a starting PEEP of 5cmH2O, a frequency of 12-18 breaths per minute titrated to the end-tidal CO2 measurement and an initial FiO2 of 0.4. An esophageal balloon catheter with pressure sensor will be used to calculate transpulmonary pressures. The balloon and pressure sensor will be calibrated as per manufacturers guideline. Respiratory parameters will be recorded and saved for later evaluation using the FluxMed GrT monitor and software (MBMED, Argentina). After inflation of the pneumoperitoneum, lung ultrasound will be performed bilaterally at the midclavicular line between the second and third ribs, at the posterior axillary line above the level of T4 and at the posterior axillary line closely superior to the diaphragm, thus retaining 6 ultrasound loops which will be saved for post-hoc lung ultrasound scoring. The lung ultrasound measurements will be repeated at different decremental levels of PEEP: 15, 10, 5 and 0 cmH2O respectively. Arterial blood gas analysis will be performed before insufflation of the pneumoperitoneum and repeated at each level of PEEP. A minimum of 4 minutes equilibration time will be provided after changing PEEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decremental PEEP | Experimental | Procedure: Decremental PEEP, Diagnostic Test: Lung ultrasound score, Diagnostic Test: Blood gas analysis, Diagnostic Test: Registration of respiratory mechanics, Diagnostic Test: Evaluation of dead spaceEvery participant will be exposed to a stepwise decremental PEEP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective laparoscopy in the Trendelenburg (head-down) position
Key exclusion criteria (3 listed)
- smoker
- lung disease (e.g. asthma, COPD, emphysema)
- BMI > 30 kg/m2
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 |
|---|---|---|
| Decremental PEEPHigh PEEP to low PEEP. | Procedure or surgery | Decremental PEEP |
| Lung ultrasound scorelung ultrasound to determine the extend of atelectasis. Uses validated lung ultrasound score. | Diagnostic test | Decremental PEEP |
| Blood gas analysisBlood gas analysis to determine arterial oxygen tension | Diagnostic test | Decremental PEEP |
| Registration of respiratory mechanicsPressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina) | Diagnostic test | Decremental PEEP |
| Evaluation of dead spaceDead space will be measured non-invasively using volumetric capnography on the FluxMed respiratory monitor (MBMED, Argentina) | Diagnostic test | Decremental PEEP |
Primary outcome
Lung ultrasound score
Time frame: Perioperatively
Lung ultrasound score per level of PEEP (15-10-5-0 cmH2O). The score is dimensionless. A cumulative count is calculated for each level of PEEP by adding the scores from the 6 scanned lung regions together. The lung ultrasound score is a measure of atelectasis.
5 secondary outcomes
Transpulmonary pressure (cmH2O)
Time frame: Perioperatively
Driving pressure (cmH2O)
Time frame: Perioperatively
Dynamic pulmonary compliance (ml/cmH2O)
Time frame: Perioperatively
P/F ratio (Horowitz index, mmHg / %)
Time frame: Perioperatively
Dead space
Time frame: Perioperatively
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 26 Jan 2022.
- Derived from this study: PubMed 36729514De Meyer GRA, Morrison SG, Saldien V, Jorens PG, Schepens T. Minimizing Lung Injury During Laparoscopy in Head-Down Tilt: A Physiological Cohort Study. Anesth Analg. 2023 Oct 1;137(4):841-849. doi: 10.1213/ANE.0000000000006325. Epub 2022 Dec 14.
- Individual participant dataSharing planned: Undecided
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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.
Vera Saldien, MD, PhD principal investigator
Head of the department of anesthesiology
Tom Schepens, MD, PhD study chair
Anesthetist/intensivist
Gregory De Meyer, MD study chair
Anesthetist in training
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decremental PEEP, Lung ultrasound score and Blood gas analysis in people with Atelectasis, run by University Hospital, Antwerp at 1 site in Belgium.
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 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 26 Jan 2022. 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 Belgium. 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?
Lung ultrasound score (time frame: Perioperatively). 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 NCT04900714, 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 26 Jan 2022.