Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery

Mechanical Ventilation Clinical Trial

— IMPROVE-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987789
• Other study ID #: IMPROVE-2 study
• Secondary ID: 2019-A00265-52
• Status: Completed
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: October 27, 2022

Study information

• Verified date: July 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: October 27, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Abdominal Surgery
• General Anesthesia
• Mechanical Ventilation
• Postoperative Morbidity

Intervention

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.
• Low PEEP
Patients will receive a PEEP level =5 cmH2O without recruitment maneuvers

Locations

Country	Name	City	State
France	University hospital	Angers
France	Hospital	Annecy
France	University hospital	Besancon
France	University Hospital	Bordeaux
France	Hospital	Chalon-sur-Saône
France	University hospital	Clermont-Ferrand
France	University hospital	Dijon
France	University hospital	Grenoble
France	University hospital	Le Mans
France	University hospital	Lille
France	University hospital	Lyon
France	University hospital	Marseile
France	Assistance Publique-Hôpitaux de Marseille	Marseille
France	Institut Paoli Calmette	Marseille
France	University hospital	Marseille
France	University hospital	Montpellier
France	University Hospital	Nantes
France	University hospital	Nice
France	University hospital	Nîmes
France	Assistance Publique-Hôpitaux de Paris	Paris
France	Hospital	Périgueux
France	University hospital	Point A Pitre
France	University hospital	Rennes
France	University hospital	Saint-Etienne
France	University hospital	Strasbourg
France	Hospital	Suresnes
France	University hospital	Toulouse
France	Hospital	Valenciennes

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	Postoperative respiratory failure	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	Hospital discharge - Up to day 30
Secondary	Postoperative pulmonary complications	Hypoxemia, pneumonia? development of acute respiratory distress syndrome (ARDS)	Day 30
Secondary	Postoperative extra-pulmonary complications	sepsis and septic shock, renal dysfunction	Day 30
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 1
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 2
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 3
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 4
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 5
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 6
Secondary	SOFA	Sequential-related Organ Failure Assessment	Day 7
Secondary	Ventilator-free days	The number of days alive and with unassisted breathing	Day 30
Secondary	Duration of invasive mechanical ventilation	Duration of invasive mechanical ventilation from randomization to first tracheal extubation	Up to Day 30
Secondary	Total duration of mechanical ventilation	Total duration of mechanical ventilation (additive, for all épisodes)	Up to Day 30
Secondary	Time to successful tracheal extubation	Absence of ventilatory support during the first 48 hours after extubation	48 hours
Secondary	Total volume of intraoperative fluids	Total volume of intraoperative fluids (crystalloids and colloids)	Day 1
Secondary	Median norepinephrine doses during surgery	µg/kg/min	Day 1
Secondary	Median phenylephrine doses during surgery	µg/kg/min	Day 1
Secondary	Median ephedrine doses during surgery	µg/kg/min	Day 1
Secondary	Intensive care unit (ICU)-free days	Intensive care unit (ICU)-free days	Day 30
Secondary	Duration of ICU stay	Duration of ICU stay	Up to day 90
Secondary	Duration of hospital stay	Duration of hospital stay	Up to day 90
Secondary	All-cause mortality	All-cause mortality	Day 30
Secondary	All-cause mortality	All-cause mortality	Day 90
Secondary	Time to death	Time to death (Days)	Up to 90 days
Secondary	Hemodynamic instability	Hemodynamic instability ventilatory-related defined as a drop of arterial systolic pressure below 80 mmHg for more than 5 minutes not responding to treatment	Up to day 30
Secondary	Pneumothorax	Pneumothorax ventilatory-related	Up to day 30