BridgeMD
New treatment option for Postoperative Complications
Official title Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)
ClinicalTrials.gov ID: NCT06101511
What this study is testing
- What it's testing
- The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- age \> 18 years; AND
- scheduled for minimally invasive abdominal surgery; AND
- at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk...
- signed written informed consent
You likely can't join if
- planned for open abdominal surgery;
- planned for surgery in lateral or prone position;
- planned for combined abdominal and intra-thoracic surgery
- confirmed pregnancy;
- consent for another treatment trial during anesthesia;
- having received invasive ventilation \> 30 minutes within the last five days;
See the full eligibility criteria
- age \> 18 years; AND
- scheduled for minimally invasive abdominal surgery; AND
- at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based...
- signed written informed consent
- planned for open abdominal surgery;
- planned for surgery in lateral or prone position;
- planned for combined abdominal and intra-thoracic surgery
- confirmed pregnancy;
- consent for another treatment trial during anesthesia;
- having received invasive ventilation \> 30 minutes within the last five days;
- any previous lung surgery;
- history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;
- history of acute respiratory distress syndrome (ARDS);
- expected to require postoperative ventilation;
- expected hemodynamic instability or intractable shock;
- severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Noordholland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Noordholland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.