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Completed

NCT Number: NCT03987789

Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

The aim of this study is to compare the effects of a strategy aimed at increasing alveolar recruitment (high PEEP levels adjusted according to driving pressure and recruitment maneuvers) with that of a strategy aimed at minimizing alveolar distension (low PEEP level without recruitment maneuver) on postoperative respiratory failure and mortality in patients receiving low VT ventilation during emergency abdominal surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital, Angers, France

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About this study

Emergency abdominal surgery is associated with a high risk of morbidity and mortality. Postoperative pulmonary complications (PPCs) are the second most common surgical complication and adversely influence surgical morbidity. Postoperative respiratory failure (PRF) is one of the most serious pulmonary complication.

Two hypotheses can be forward by the literature. First, a low VT lung protective ventilation in combination with a strategy aimed at minimizing alveolar distension by using low PEEP level (and without recruitment maneuver) could improve postoperative outcome while reducing the risk of hemodynamic alterations or, second, could increase the risk of PRF compared with a strategy aimed at increasing alveolar recruitment using higher PEEP level adjusted according to driving pressure in combination with recruitment maneuvers in adult patients undergoing emergency abdominal surgery. Given the uncertainties, and in order to determine the impact of lung protective ventilation strategies on clinical outcomes of high-risk surgical patients, a randomized trial is needed.

Our primary hypothesis is that, during low VT ventilation, a strategy aimed at increasing alveolar recruitment by using high PEEP levels adjusted according to driving pressure in combination with recruitment maneuvers could be more effective at reducing PRF and mortality after emergency abdominal surgery than a strategy aimed at minimizing alveolar distension by using lower PEEP without recruitment maneuver.

Given the number of patients for whom the question applies, the prevalence and the burden of PPCs, the study can have significant clinical importance and public health implications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (≥18 years)
  • Patients requiring emergency (defined by the need to proceed to surgery within a few hours after diagnosis)
  • Laparoscopic or non-laparoscopic abdominal surgery under general anesthesia and with an expected duration of at least two hours

Exclusion criteria

  • Patients already receiving mechanical ventilation for more than 12 hours before enrollment
  • Intracranial hypertension
  • Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home
  • Undrained pneumothorax or subcutaneous emphysema
  • Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 month
  • Body mass index (BMI) >40 kg/m2
  • Pregnant or breastfeeding women
  • Patients already enrolled in the IMPROVE-2 trial
  • Participation in a confounding trial with mortality or PRF as the main endpoint
  • Patient's or relative's refusal to participate
  • Guardianship or trusteeship patient
  • No affiliation to the Social Security system

Treatment and study plan

Driving-pressure-guided group

Other

Patients will receive PEEP levels individually set at the highest possible value (up to 15 cmH2O) providing a driving pressure (airway plateau pressure minus PEEP) lower than 13 cmH2O, in addition to recruitment maneuvers.

Low PEEP

Other

Patients will receive a PEEP level ≤5 cmH2O without recruitment maneuvers

Primary outcomes

  1. Postoperative respiratory failure

    Time frame: Hospital discharge - Up to day 30

    Composite criteria :

    • - Failure to wean from the ventilator after surgery (Yes or No)
    • - Requiring unplanned reintubation (Yes or No)
    • - Curative non-invasive ventilation once extubated postoperatively (Yes or No)
    • - Death (all cause of mortality) (Yes or No)

    If at least one of these 4 criteria is answered yes, the composite criterion (i.e. the primary outcome) will be answered yes

Secondary outcomes

  1. Postoperative pulmonary complications

    Time frame: Day 30

    Hypoxemia, pneumonia? development of acute respiratory distress syndrome (ARDS)

  2. Postoperative extra-pulmonary complications

    Time frame: Day 30

    sepsis and septic shock, renal dysfunction

  3. SOFA

    Time frame: Day 1

    Sequential-related Organ Failure Assessment

  4. SOFA

    Time frame: Day 2

    Sequential-related Organ Failure Assessment

  5. SOFA

    Time frame: Day 3

    Sequential-related Organ Failure Assessment

  6. SOFA

    Time frame: Day 4

    Sequential-related Organ Failure Assessment

  7. SOFA

    Time frame: Day 5

    Sequential-related Organ Failure Assessment

  8. SOFA

    Time frame: Day 6

    Sequential-related Organ Failure Assessment

  9. SOFA

    Time frame: Day 7

    Sequential-related Organ Failure Assessment

  10. Ventilator-free days

    Time frame: Day 30

    The number of days alive and with unassisted breathing

  11. Duration of invasive mechanical ventilation

    Time frame: Up to Day 30

    Duration of invasive mechanical ventilation from randomization to first tracheal extubation

  12. Total duration of mechanical ventilation

    Time frame: Up to Day 30

    Total duration of mechanical ventilation (additive, for all épisodes)

  13. Time to successful tracheal extubation

    Time frame: 48 hours

    Absence of ventilatory support during the first 48 hours after extubation

  14. Total volume of intraoperative fluids

    Time frame: Day 1

    Total volume of intraoperative fluids (crystalloids and colloids)

  15. Median norepinephrine doses during surgery

    Time frame: Day 1

    µg/kg/min

  16. Median phenylephrine doses during surgery

    Time frame: Day 1

    µg/kg/min

  17. Median ephedrine doses during surgery

    Time frame: Day 1

    µg/kg/min

  18. Intensive care unit (ICU)-free days

    Time frame: Day 30

    Intensive care unit (ICU)-free days

  19. Duration of ICU stay

    Time frame: Up to day 90

    Duration of ICU stay

  20. Duration of hospital stay

    Time frame: Up to day 90

    Duration of hospital stay

  21. All-cause mortality

    Time frame: Day 30

    All-cause mortality

  22. All-cause mortality

    Time frame: Day 90

    All-cause mortality

  23. Time to death

    Time frame: Up to 90 days

    Time to death (Days)

  24. Hemodynamic instability

    Time frame: Up to day 30

    Hemodynamic instability ventilatory-related defined as a drop of arterial systolic pressure below 80 mmHg for more than 5 minutes not responding to treatment

  25. Pneumothorax

    Time frame: Up to day 30

    Pneumothorax ventilatory-related

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial

Acronym: IMPROVE-2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 17, 2019
Registry last updated
Apr 21, 2026

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.

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