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Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position (optiPEEP)

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Decremental PEEP
Lung ultrasound score
Blood gas analysis
Registration of respiratory mechanics
Evaluation of dead space
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atelectasis focused on measuring Positive-Pressure Respiration, Respiratory Mechanics, positive end-expiratory pressure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Elective laparoscopy in the Trendelenburg (head-down) position

Exclusion Criteria:

  • smoker
  • lung disease (e.g. asthma, COPD, emphysema)
  • BMI > 30 kg/m2

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Decremental PEEP

Arm Description

Every participant will be exposed to a stepwise decremental PEEP.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Dead space
Median dead space per level of PEEP (15-10-5-0 cmH2O).

Full Information

First Posted
September 24, 2020
Last Updated
January 25, 2022
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT04900714
Brief Title
Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position
Acronym
optiPEEP
Official Title
Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
Positive-Pressure Respiration, Respiratory Mechanics, positive end-expiratory pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decremental PEEP
Arm Type
Experimental
Arm Description
Every participant will be exposed to a stepwise decremental PEEP.
Intervention Type
Procedure
Intervention Name(s)
Decremental PEEP
Intervention Description
High PEEP to low PEEP.
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound score
Intervention Description
lung ultrasound to determine the extend of atelectasis. Uses validated lung ultrasound score.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood gas analysis
Intervention Description
Blood gas analysis to determine arterial oxygen tension
Intervention Type
Diagnostic Test
Intervention Name(s)
Registration of respiratory mechanics
Intervention Description
Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of dead space
Intervention Description
Dead space will be measured non-invasively using volumetric capnography on the FluxMed respiratory monitor (MBMED, Argentina)
Primary Outcome Measure Information:
Title
Lung ultrasound score
Description
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.
Time Frame
Perioperatively
Secondary Outcome Measure Information:
Title
Transpulmonary pressure (cmH2O)
Description
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.
Time Frame
Perioperatively
Title
Driving pressure (cmH2O)
Description
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.
Time Frame
Perioperatively
Title
Dynamic pulmonary compliance (ml/cmH2O)
Description
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.
Time Frame
Perioperatively
Title
P/F ratio (Horowitz index, mmHg / %)
Description
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.
Time Frame
Perioperatively
Title
Dead space
Description
Median dead space per level of PEEP (15-10-5-0 cmH2O).
Time Frame
Perioperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Elective laparoscopy in the Trendelenburg (head-down) position Exclusion Criteria: smoker lung disease (e.g. asthma, COPD, emphysema) BMI > 30 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD, PhD
Organizational Affiliation
Head of the department of anesthesiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Schepens, MD, PhD
Organizational Affiliation
Anesthetist/intensivist
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gregory De Meyer, MD
Organizational Affiliation
Anesthetist in training
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stuart G Morrison, MD
Organizational Affiliation
Staff anesthetist
Official's Role
Study Director
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Minimizing Lung Injury During Laparoscopy in Steep Trendelenburg Position

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