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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 18, 2011
Last Updated Date	October 4, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 24, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01282996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 17, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 24, 2011)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)
Official Title ^ICMJE	Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Protective Lung Ventilation Using: Low Tidal Volume (6-8 mL/kg Predicted Body Weight) PEEP of 6-8 cmH2O Intraoperative RMs
Intervention ^ICMJE	Other: Abdominal surgery to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date	August 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01282996
Other Study ID Numbers ^ICMJE	CHU-0087
Has Data Monitoring Committee	Not Provided
Responsible Party	University Hospital, Clermont-Ferrand
Study Sponsor ^ICMJE	University Hospital, Clermont-Ferrand
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Clermont-Ferrand
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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