Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

Intraoperative RMs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282996
• Other study ID #: CHU-0087
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2011
• Last updated: October 4, 2012
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism		at day 15 after surgery	Yes
Secondary	Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess		at day 15 after surgery	Yes
Secondary	Other postoperative complications (reintervention, wound abscess, ...)		at day 15 after surgery	Yes
Secondary	Systemic level of marker of inflammation (C Reactive protein)		at day 15 after surgery	Yes
Secondary	Postoperative complications at day 30 after surgery		at day 30 after surgery	Yes
Secondary	Need for ICU admission		at day 30 after surgery	Yes
Secondary	ICU length of stay		at day 30 after surgery	Yes
Secondary	Hospital length of stay		at day 30 after surgery	Yes
Secondary	Mortality		at day 30 after surgery	No
Secondary	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	Yes