Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01282996
First received: January 18, 2011
Last updated: October 4, 2012
Last verified: October 2012

January 18, 2011
October 4, 2012
January 2011
August 2012   (final data collection date for primary outcome 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 [ Time Frame: during the first seven days after surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01282996 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)
Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Protective Lung Ventilation Using:
  • Low Tidal Volume (6-8 mL/kg Predicted Body Weight)
  • PEEP of 6-8 cmH2O
  • Intraoperative RMs
Other: Abdominal surgery
to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01282996
CHU-0087
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Not Provided
University Hospital, Clermont-Ferrand
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP