The overall objective of this RCT is to determine the effectiveness and long-term outcome of an high PEEP strategy, aiming at preventing atelectasis, but avoiding an increase in driving pressure, during intraoperative ventilation. Specifically, this…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is a composite of PPCs in the first 5 postoperative
days.
Secondary outcome
• Intraoperative fluid strategy
• Intraoperative complications including:
- Desaturations
- Hypotensions
- Need for vasoactive medications
- New arrhythmias needing intervention
• Impaired wound healing
• Postoperative extrapulmonary complications
• All-cause mortality at day 5, day 90 and day 90
• Unplanned admission to an intensive care and length of stay in Intensive care
unit
• Length of hospital stay.
Background summary
Postoperative pulmonary complications (PPCs) develop frequently in patients
undergoing major surgery. PPCs are strongly associated with a longer hospital
stay and mortality. Use of a 'lung protective' intraoperative ventilation
strategy prevents against PPC's, though there is debate on which ventilator
setting is most effective. Intraoperative driving pressure is strongly
associated with the development of PPCs.
Study objective
The overall objective of this RCT is to determine the effectiveness and
long-term outcome of an high PEEP strategy, aiming at preventing atelectasis,
but avoiding an increase in driving pressure, during intraoperative
ventilation. Specifically, this will be a superiority trial comparing
individualized high positive end expiratory pressure (PEEP) with standard low
PEEP in patients at increased risk of developing PPC's.
Study design
International multicenter double blinded randomized controlled trial
Intervention
An individualized high PEEP, aiming at avoiding an increase in the driving
pressure will be compared to a standard low PEEP during intraoperative
ventilation.
Study burden and risks
During surgery, the patient is under general anesthesia and will therefore not
notice the use of lung-protective ventilation. There is little extra risk for
the patient. However, when using higher airway pressures it can be necessary to
administer extra fluid in the circulation or medication to increase the blood
pressure. Patients in the intervention group could benefit from lung-protective
ventilation, which potentially decreases their risk of development of PPCs.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Increased (i.e., intermediate or high) risk of postoperative pulmonary
complications (according to the ARISCAT risk score [>= 26] , Scheduled for open
abdominal surgery in one of the participating centers
Exclusion criteria
Planned for laparoscopic surgery;
Planned for surgery in prone or lateral position;
Planned combined procedure with open abdominal and intrathoracic surgery;
Age < 18 years;
Body mass index > 40 kg/m2;
Reported pregnancy;
Having received mechanical ventilation for longer than 30 minutes (e.g.,
because of general anesthesia for surgery) within last 30 days;
Any major previous lung surgery;
History of previous severe chronic obstructive pulmonary disease (COPD) GOLD
III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
(previous) acute respiratory distress syndrome (ARDS);
Expected to require postoperative mechanical ventilation;
Persistent hemodynamic instability or intractable shock;
Severe cardiac disease (New York Heart Association class III or IV, or acute
coronary syndrome, or persistent ventricular tachyarrhythmia*s);
Consent for another interventional study in anesthesiology; or
No written informed consent
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03884543 |
| CCMO | NL67684.018.18 |