Clinical trial NCT01282996: Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)
Official title: Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Protective Lung Ventilation Using:
Low Tidal Volume (6-8 mL/kg Predicted Body Weight)
PEEP of 6-8 cmH2O
Intraoperative RMs
Keywords: Mechanical ventilation
Postoperative pulmonary complications
Positive end-expiratory pressure
Protective lung ventilation
Alveolar recruitment maneuver
General anesthesia
Abdominal surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 criteria: 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

Primary outcomes:
measure: 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
timeFrame: during the first seven days after surgery
Secondary outcomes:
measure: Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism
timeFrame: at day 15 after surgery
measure: Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess
timeFrame: at day 15 after surgery
measure: Other postoperative complications (reintervention, wound abscess, ...)
timeFrame: at day 15 after surgery
measure: Systemic level of marker of inflammation (C Reactive protein)
timeFrame: at day 15 after surgery
measure: Postoperative complications at day 30 after surgery
timeFrame: at day 30 after surgery
measure: Need for ICU admission
timeFrame: at day 30 after surgery
measure: ICU length of stay
timeFrame: at day 30 after surgery
measure: Hospital length of stay
timeFrame: at day 30 after surgery
measure: Mortality
timeFrame: at day 30 after surgery
measure: Plasma levels of the soluble form of the receptor for advanced glycation end-products (sRAGE), a marker of alveolar type I cell injury
timeFrame: before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
References:
citation: Neuschwander A, Futier E, Jaber S, Pereira B, Eurin M, Marret E, Szymkewicz O, Beaussier M, Paugam-Burtz C. The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE). Eur J Anaesthesiol. 2016 Apr;33(4):292-8. doi: 10.1097/EJA.0000000000000390.
citation: Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.