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出境医 / 临床实验 / Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery (IMPROVE-2)
Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery (IMPROVE-2)
Study Description
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.
Study Design
| 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 |
| Actual Study Start Date : | February 18, 2021 |
| Estimated Primary Completion Date : | March 18, 2023 |
| Estimated Study Completion Date : | May 18, 2023 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- Postoperative pulmonary complications [ Time Frame: Day 30 ]Hypoxemia, pneumonia? development of acute respiratory distress syndrome (ARDS)
- Postoperative extra-pulmonary complications [ Time Frame: Day 30 ]sepsis and septic shock, renal dysfunction
- SOFA [ Time Frame: Day 1 ]Sequential-related Organ Failure Assessment
- SOFA [ Time Frame: Day 2 ]Sequential-related Organ Failure Assessment
- SOFA [ Time Frame: Day 3 ]Sequential-related Organ Failure Assessment
- SOFA [ Time Frame: Day 4 ]Sequential-related Organ Failure Assessment
- SOFA [ Time Frame: Day 5 ]Sequential-related Organ Failure Assessment
- SOFA [ Time Frame: Day 6 ]Sequential-related Organ Failure Assessment
- SOFA [ Time Frame: Day 7 ]Sequential-related Organ Failure Assessment
- Ventilator-free days [ Time Frame: Day 30 ]The number of days alive and with unassisted breathing
- Duration of invasive mechanical ventilation [ Time Frame: Up to Day 30 ]Duration of invasive mechanical ventilation from randomization to first tracheal extubation
- Total duration of mechanical ventilation [ Time Frame: Up to Day 30 ]Total duration of mechanical ventilation (additive, for all épisodes)
- Time to successful tracheal extubation [ Time Frame: 48 hours ]Absence of ventilatory support during the first 48 hours after extubation
- Total volume of intraoperative fluids [ Time Frame: Day 1 ]Total volume of intraoperative fluids (crystalloids and colloids)
- Median norepinephrine doses during surgery [ Time Frame: Day 1 ]µg/kg/min
- Median phenylephrine doses during surgery [ Time Frame: Day 1 ]µg/kg/min
- Median ephedrine doses during surgery [ Time Frame: Day 1 ]µg/kg/min
- Intensive care unit (ICU)-free days [ Time Frame: Day 30 ]Intensive care unit (ICU)-free days
- Duration of ICU stay [ Time Frame: Up to day 90 ]Duration of ICU stay
- Duration of hospital stay [ Time Frame: Up to day 90 ]Duration of hospital stay
- All-cause mortality [ Time Frame: Day 30 ]All-cause mortality
- All-cause mortality [ Time Frame: Day 90 ]All-cause mortality
- Time to death [ Time Frame: Up to 90 days ]Time to death (Days)
- 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
- Pneumothorax [ Time Frame: Up to day 30 ]Pneumothorax ventilatory-related
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Lise Laclautre | 33 4 73 754 963 | promo_interne_drci@chu-clermontferrand.fr |
Locations
Show 32 study locations
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
| Principal Investigator: | Emmanuel Futier | CHU de Clermont-Ferrand |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 12, 2019 | ||||
| First Posted Date ICMJE | June 17, 2019 | ||||
| Last Update Posted Date | April 21, 2021 | ||||
| Actual Study Start Date ICMJE | February 18, 2021 | ||||
| Estimated Primary Completion Date | March 18, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Postoperative respiratory failure [ Time Frame: Hospital discharge - Up to day 30 ] Composite criteria :
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery | ||||
| Official Title ICMJE | Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery: IMPROVE-2 Multicenter Prospective Randomized Trial | ||||
| 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. | ||||
| 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 ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
680 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 18, 2023 | ||||
| Estimated Primary Completion Date | March 18, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03987789 | ||||
| Other Study ID Numbers ICMJE | IMPROVE-2 study 2019-A00265-52 ( Other Identifier: ANSM ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | University Hospital, Clermont-Ferrand | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University Hospital, Clermont-Ferrand | ||||
| Verification Date | July 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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