Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Protective Lung Ventilation Using:; Low Tidal Volume (6-8 mL/kg Predicted Body Weight); PEEP of 6-8 cmH2O; Intraoperative RMs
• Intervention / Treatment: Other: 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: Interventional
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Need for ICU admission	at day 30 after surgery
ICU length of stay	at day 30 after surgery
Hospital length of stay	at day 30 after surgery
Mortality	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	before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; Mechanical ventilation; Abdominal surgery; Positive end-expiratory pressure; General anesthesia; Alveolar recruitment maneuver; Protective lung ventilation
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: CHU-0087