This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand Identifier:
First received: January 18, 2011
Last updated: October 4, 2012
Last verified: October 2012
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism [ Time Frame: at day 15 after surgery ]
  • Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess [ Time Frame: at day 15 after surgery ]
  • Other postoperative complications (reintervention, wound abscess, ...) [ Time Frame: at day 15 after surgery ]
  • Systemic level of marker of inflammation (C Reactive protein) [ Time Frame: at day 15 after surgery ]
  • Postoperative complications at day 30 after surgery [ Time Frame: at day 30 after surgery ]
  • Need for ICU admission [ Time Frame: at day 30 after surgery ]
  • ICU length of stay [ Time Frame: at day 30 after surgery ]
  • Hospital length of stay [ Time Frame: at day 30 after surgery ]
  • Mortality [ Time Frame: at day 30 after surgery ]
  • 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 ]

Enrollment: 400
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Abdominal surgery
    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.


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01282996

Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01282996     History of Changes
Other Study ID Numbers: CHU-0087
Study First Received: January 18, 2011
Last Updated: October 4, 2012

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 processed this record on August 17, 2017