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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Antwerp University Hospital

    Edegem, Antwerp, 2650

Other trials in Belgium

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

  1. measure apical versus basal atelectasis using the lung ultrasound score
  2. compare lung ultrasound scores at different PEEP levels
  3. compare respiratory mechanics at the different PEEP levels
  4. contrast the optimal PEEP level to standard practice
  5. 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 groups in NCT04900714
Study groupRoleWhat they receive
Decremental PEEPExperimentalEvery 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted25 May 2021
  2. Study start21 Jun 2021
  3. Primary completion23 Sep 2021
  4. Study completion23 Sep 2021

Resources

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)
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

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.

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