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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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 ] [ 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 ]

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282996

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

No publications provided by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 4, 2012
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 April 14, 2014