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Completed

NCT Number: NCT01282996

Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE 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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abdominal surgery

Other

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

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

    Time frame: during the first seven days after surgery

Secondary outcomes

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

    Time frame: at day 15 after surgery

  2. Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess

    Time frame: at day 15 after surgery

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

    Time frame: at day 15 after surgery

  4. Systemic level of marker of inflammation (C Reactive protein)

    Time frame: at day 15 after surgery

  5. Postoperative complications at day 30 after surgery

    Time frame: at day 30 after surgery

  6. Need for ICU admission

    Time frame: at day 30 after surgery

  7. ICU length of stay

    Time frame: at day 30 after surgery

  8. Hospital length of stay

    Time frame: at day 30 after surgery

  9. Mortality

    Time frame: at day 30 after surgery

  10. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2011
Registry last updated
Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.