|- candidate number||8460|
|- NTR Number||NTR2517|
|- Date ISRCTN created||6-dec-2010|
|- date ISRCTN requested||29-okt-2010|
|- Date Registered NTR||16-sep-2010|
|- Secondary IDs||NL33848.018.10 / 10/251 / 01441791; CCMO / MEC AMC / ClinicalTrials|
|- Public Title||Protective mechanical ventilation during surgery on the abdomen with general anesthesia.|
|- Scientific Title||Protective Ventilation During General Anesthesia for Abdominal Surgery: A Randomized Controlled Trial.|
|- hypothesis||Post–operative respiratory failure, in particular after abdominal surgery and general anesthesia, adds to morbidity and mortality of surgical patients. Lung–protective mechanical ventilation, with the use of positive end–expiratory pressure (PEEP) and recruitment maneuvers, has the potential to prevent lung injury in patients with injured lungs. It is the question whether PEEP and recruitment also protects the lungs in patients without previous lung injury. |
|- Healt Condition(s) or Problem(s) studied||Post-operative respiratory failure|
|- Inclusion criteria||1. Planned elective abdominal surgery;|
2. General anesthesia with intravenous medication;
3. High or intermediate risk for postoperative pulmonary complications.
|- Exclusion criteria||1. Age < 18 years;|
2. Body mass index > 40 kg/m2;
3. Laparoscopic surgery;
4. Previous lung surgery (any);
5. Persistent hemodynamic instability, intractable shock (considered hemodynamic unsuitable for the study by the patient’s managing physician);
6. History of previous severe chronic obstructive pulmonary disease (COPD) (non–invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD);
7. Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy, less than 2 months after chemotherapy or radiation therapy);
8. Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia’s);
9. Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days;
10. Pregnancy (excluded by laboratory analysis);
11. Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation;
12. Neuromuscular disease (any);
13. Consented for another interventional study or refusal to participate in the study.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||1-feb-2013|
|- Target number of participants||900|
|- Interventions||1. The conventional group will be ventilated with low PEEP (max 2cm H2O), without recruitment;|
2. The interventional groep will be ventilated with higher PEEP (12cm H2O), with intra-operative recruitment maneuvres.
|- Primary outcome||Postoperative pulmonary complications:|
1. Mild or severe respiratory failure;
3. Suspected pulmonary infection;
4. Pulmonary infiltrate on chest X-ray;
8. Aspiration pneumonitis;
9. Cardiopulmonary edema.
|- Secondary outcome||1. Intra–operative complications (desaturation, barotrauma, hypotension during recruitment, need for vasopressors);|
2. Need for ICU admission (if not as part of routine) or ICU readmission;
3. Hospital–free days at day 90;
4. Post–operative non–pulmonary organ function;
5. Post–operative wound healing;
6. Systemic levels of markers of pulmonary inflammation, acute lung injury and markers of distal organ injury.
|- Timepoints||1. Pre-operative;|
3. Post-operative on day 1, 2, 3, 4 and 5.
|- Trial web site||https://sites.google.com/site/provhilo/|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. Marcus J. Schultz|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. Marcus J. Schultz|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Dutch Ministry of Education, Culture and Science|
|- Publications||Hemmes et al, Trials 2011, 12:111|
|- Brief summary||Background of the study:|
Post-operative respiratory failure, in particular after abdominal surgery and general anesthesia > 2 hours, adds to morbidity and mortality of surgical patients. Lung-protective mechanical ventilation, with the use of positive end-expiratory
pressure (PEEP) and recruitment maneuvers, has the potential to prevent lung injury in patients with injured lungs. It is the
question whether PEEP and recruitment also protects the lungs in patients without previous lung injury.
Objective of the study:
The present study aims at comparing the post-operative lung injury of a lung-protective mechanical ventilation strategy
(with the use of higher levels of PEEP and intra-operative recruitment maneuvers) with conventional mechanical
ventilation (lower levels of PEEP without recruitment) during abdominal non-laparoscopic surgery in patients at high or
intermediate risk for post-operative respiratory failure.
Multinational multicentre randomized controlled trial.
In total: 900 patients.
In The Netherlands: 100 patients.
The conventional group will be ventilated with low PEEP (maximum 2cm H2O), without recruitment.
The interventional groep will be ventilated with higher PEEP (12cm H2O), with intra-operative recruitment
Primary study parameters/outcome of the study:
Post-operative pulmonary complications (for definitions see appendix ii):
Mild respiratory failure, severe respiratory failure, ALI/ARDS, suspected pulmonary infection, pulmonary infiltrate, pleural
effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, cardiopulmonary edema.
Secundary study parameters/outcome of the study:
Intra-operative complications, need for ICU admission (if not as part of routine) or ICU readmission, hospital-free days at
day 90, post-operative non-pulmonary organ function (see appendix ii); post-operative wound healing; systemic levels of
markers of pulmonary inflammation, acute lung injury and markers of distal organ injury.
|- Main changes (audit trail)|
|- RECORD||16-sep-2010 - 26-jan-2013|