Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Protective Lung Ventilation Using: Low Tidal Volume (6-8 mL/kg Predicted Body Weight) PEEP of 6-8 cmH2O Intraoperative RMs

Keywords

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Mechanical ventilation Postoperative pulmonary complications Positive end-expiratory pressure Protective lung ventilation Alveolar recruitment maneuver General anesthesia Abdominal surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Abdominal surgery

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

References

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Neuschwander A, Futier E, Jaber S, Pereira B, Eurin M, Marret E, Szymkewicz O, Beaussier M, Paugam-Burtz C. The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE). Eur J Anaesthesiol. 2016 Apr;33(4):292-8. doi: 10.1097/EJA.0000000000000390.

Reference Type DERIVED

PMID: 26716865 (View on PubMed)

Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.