Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Protective Lung Ventilation Using: Low Tidal Volume (6-8 mL/kg Predicted Body Weight) PEEP of 6-8 cmH2O Intraoperative RMs |
Other: Abdominal surgery |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study |
- Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications [ Time Frame: during the first seven days after surgery ] [ Designated as safety issue: Yes ]
- Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism [ Time Frame: at day 15 after surgery ] [ Designated as safety issue: Yes ]
- Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess [ Time Frame: at day 15 after surgery ] [ Designated as safety issue: Yes ]
- Other postoperative complications (reintervention, wound abscess, ...) [ Time Frame: at day 15 after surgery ] [ Designated as safety issue: Yes ]
- Systemic level of marker of inflammation (C Reactive protein) [ Time Frame: at day 15 after surgery ] [ Designated as safety issue: Yes ]
- Postoperative complications at day 30 after surgery [ Time Frame: at day 30 after surgery ] [ Designated as safety issue: Yes ]
- Need for ICU admission [ Time Frame: at day 30 after surgery ] [ Designated as safety issue: Yes ]
- ICU length of stay [ Time Frame: at day 30 after surgery ] [ Designated as safety issue: Yes ]
- Hospital length of stay [ Time Frame: at day 30 after surgery ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: at day 30 after surgery ] [ Designated as safety issue: No ]
- Plasma levels of the soluble form of the receptor for advanced glycation end-products (sRAGE), a marker of alveolar type I cell injury [ Time Frame: before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
-
Other: Abdominal surgery
Postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support.
Recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (TV) without positive end-expiratory pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. Conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation.
The primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM.
Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Planned intrabdominal surgery
- Expected duration ≥ 2 hours
- Age ≥ 40 yr (and <90 yr)
- Risk of postoperative pulmonary complications (Arozullah score ≥2)
Exclusion Criteria:
- Noninvasive ventilation in the last 30 days
- Recent history of pneumonia, ALI/ARDS (in the last 30 days)
- History of pulmonary resection
- History of neuromuscular disease
- Patient refusal
Contacts and Locations| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| France | |
| Chu Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
| Principal Investigator: Emmanuel FUTIER | |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01282996 History of Changes |
| Other Study ID Numbers: | CHU-0087 |
| Study First Received: | January 18, 2011 |
| Last Updated: | November 17, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Mechanical ventilation Postoperative pulmonary complications Positive end-expiratory pressure Protective lung ventilation |
Alveolar recruitment maneuver General anesthesia Abdominal surgery |
Additional relevant MeSH terms:
|
Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on September 26, 2012
