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Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery (IMPROVE-2)

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ClinicalTrials.gov Identifier: NCT03987789
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Emergency Abdominal Surgery Mechanical Ventilation General Anesthesia Postoperative Morbidity Other: Driving-pressure-guided group Other: Low PEEP Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, prospective, randomized, stratified, parallel-group clinical trial with blinded outcome assessment and concealed allocation of patients undergoing emergency abdominal surgery using low VT lung-protective ventilation to a strategy of minimal alveolar distension using low PEEP level or to a strategy aimed at increasing alveolar recruitment (higher PEEP level individually titrated to minimize the driving pressure in addition to recruitment maneuvers)
Masking: Single (Outcomes Assessor)
Masking Description: It will not be possible to mask the assigned ventilation strategy from the treating clinicians because they have an ethical responsibility to ensure patient safety during the emergency procedures. However, procedures will be put in place to minimize the possibility of bias arising because research staff becomes aware of trial group allocation. At each participating center, patients will be followed up for primary and secondary endpoints by members of the research staff who will be unaware of the trial group allocation. Information on whether the primary and secondary outcomes occur will be collected and entered into the electronic web-based case report form (eCRF) by trial or clinical trained personal (clinical research associate), blinded to the allocation group, under the supervision of the local principal investigator (PI) or designee who will also be unaware of the trial group allocation.
Primary Purpose: Treatment
Official Title: Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Active Comparator: Low PEEP group
Patients will receive a PEEP level ≤5 cmH2O without recruitment maneuvers
Other: Low PEEP
Patients will receive a PEEP level ≤5 cmH2O without recruitment maneuvers

Experimental: Driving-pressure-guided group
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
Other: Driving-pressure-guided group
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.




Primary Outcome Measures :
  1. Postoperative respiratory failure [ Time Frame: Hospital discharge - Up to day 30 ]

    Composite criteria :

    1. - Failure to wean from the ventilator after surgery (Yes or No)
    2. - Requiring unplanned reintubation (Yes or No)
    3. - Curative non-invasive ventilation once extubated postoperatively (Yes or No)
    4. - 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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987789


Contacts
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Contact: Lise Laclautre 33 4 73 754 963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
University hospital
Angers, France
University hospital Not yet recruiting
Besancon, France
Contact: Emmanuel Samain         
University hospital Not yet recruiting
Bordeaux, France
Contact: Alexandre Ouattara         
Hospital Not yet recruiting
Chalon-sur-Saône, France
Contact: Stéphanie Javelier         
University hospital
Dijon, France
University hospital Not yet recruiting
Grenoble, France
Contact: Pierre Bouzat         
University hospital Not yet recruiting
Le Mans, France
Contact: Charlène Le Moal         
University hospital Not yet recruiting
Lille, France
Contact: Gilles Lebuffe         
University hospital Not yet recruiting
Lille, France
Contact: Benoit Tavernier         
University hospital Not yet recruiting
Lyon, France
Contact: Jean-Stephane David         
University hospital Not yet recruiting
Lyon, France
Contact: Thomas Rimmele         
University hospital Not yet recruiting
Marseile, France
Contact: Nicolas Bruder         
University hospital
Marseille, France
University hospital Not yet recruiting
Montpellier, France
Contact: Samir Jaber         
University hospital Not yet recruiting
Nantes, France
Contact: Karim Asehnoune         
University hospital Not yet recruiting
Nîmes, France
Contact: Laurent Muller         
Assistance Publique-Hôpitaux de Paris Not yet recruiting
Paris, France
Contact: Lescot Thomas         
University hospital Not yet recruiting
Rennes, France
Contact: Helene Beloeil         
University hospital Not yet recruiting
Saint-Etienne, France
Contact: Molliex Serge         
University hospital Not yet recruiting
Strasbourg, France
Contact: Olivier Collange,         
University hospital Not yet recruiting
Strasbourg, France
Contact: Julien Pottecher         
University hospital Not yet recruiting
Toulouse, France
Contact: Vincent Minville         
Hospital Not yet recruiting
Valenciennes, France
Contact: Younes El Amine         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Emmanuel Futier CHU de Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03987789     History of Changes
Other Study ID Numbers: IMPROVE-2 study
2019-A00265-52 ( Other Identifier: ANSM )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Mechanical Ventilation
Lung-Protective Ventilation
Postoperative Pulmonary Complications
Postoperative morbidity

Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes