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Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

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ClinicalTrials.gov Identifier: NCT01282996
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : October 5, 2012
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
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
Study Start Date : January 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Intervention Details:
  • Other: Abdominal surgery
    to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery

Primary Outcome Measures :
  1. 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 :
  1. Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism [ Time Frame: at day 15 after surgery ]
  2. Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess [ Time Frame: at day 15 after surgery ]
  3. Other postoperative complications (reintervention, wound abscess, ...) [ Time Frame: at day 15 after surgery ]
  4. Systemic level of marker of inflammation (C Reactive protein) [ Time Frame: at day 15 after surgery ]
  5. Postoperative complications at day 30 after surgery [ Time Frame: at day 30 after surgery ]
  6. Need for ICU admission [ Time Frame: at day 30 after surgery ]
  7. ICU length of stay [ Time Frame: at day 30 after surgery ]
  8. Hospital length of stay [ Time Frame: at day 30 after surgery ]
  9. Mortality [ Time Frame: at day 30 after surgery ]
  10. 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 ]

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282996

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Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01282996    
Other Study ID Numbers: CHU-0087
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 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:
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Body Weight