Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

NCT01282996 | Completed Phase 4

• 1 other identifier: CHU-0087
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Protective Lung Ventilation Using:; Low Tidal Volume (6-8 mL/kg Predicted Body Weight); PEEP of 6-8 cmH2O; Intraoperative RMs

Keywords

Mechanical ventilation; Postoperative pulmonary complications; Positive end-expiratory pressure; Protective lung ventilation; Alveolar recruitment maneuver; General anesthesia; Abdominal surgery

Outcome Measures

Primary Outcomes (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

  during the first seven days after surgery

Secondary Outcomes (10)

• Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism

  at day 15 after surgery

• Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess

  at day 15 after surgery

• Other postoperative complications (reintervention, wound abscess, ...)

  at day 15 after surgery

• Systemic level of marker of inflammation (C Reactive protein)

  at day 15 after surgery

• Postoperative complications at day 30 after surgery

  at day 30 after surgery

Interventions

Abdominal surgery OTHER

to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned intrabdominal surgery
• Expected duration ≥ 2 hours
• Age ≥ 40 yr (and \<90 yr)
• Risk of postoperative pulmonary complications (Arozullah score ≥2)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

• Neuschwander A, Futier E, Jaber S, Pereira B, Eurin M, Marret E, Szymkewicz O, Beaussier M, Paugam-Burtz C. The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE). Eur J Anaesthesiol. 2016 Apr;33(4):292-8. doi: 10.1097/EJA.0000000000000390.

  PMID: 26716865 DERIVED

• 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.

  PMID: 23902482 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 25, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

FR (1)