PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery - Full Text View

Purpose

The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery.

Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.

Condition	Intervention
Postoperative Respiratory Complications	Procedure: Lung protective strategy ventilation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Protective Ventilation During General Anesthesia for Open Abdominal Surgery - a Randomized Controlled Trial

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:

Post-operative pulmonary complications (PPCs) [ Time Frame: first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up. ] [ Designated as safety issue: Yes ]
Mild respiratory failure Severe respiratory failure ALI/ARDS (Acute Lung Injury and Acute Respiratory Distress Syndrome) Suspected pulmonary infection Pulmonary infiltrate Pleural effusion Atelectasis Pneumothorax Bronchospasm Aspiration pneumonitis Cardiopulmonary edema

Secondary Outcome Measures:

Post-operative extra-pulmonary complications [ Time Frame: first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up ] [ Designated as safety issue: Yes ]
Intra-operative mechanical ventilation related complications [ Time Frame: during the length of anesthesia, which will be an estimated 2 to 5 hours ] [ Designated as safety issue: Yes ]
Unscheduled Intensive Care Unit (ICU) (re-) admission [ Time Frame: first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up ] [ Designated as safety issue: Yes ]
Length of hospital stay on day 90 [ Time Frame: until day 90 post-operative ] [ Designated as safety issue: No ]

Enrollment:	900
Study Start Date:	February 2011
Study Completion Date:	April 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lung protective strategy ventilation Lung protective strategy ventilation: PEEP at 12 cmH2O, Recruitment maneuvers (after intubation, after any disconnection from the mechanical ventilator, directly before detubation)	Procedure: Lung protective strategy ventilation Patients are randomized and intra-operatively ventilated with a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers)
No Intervention: Conventional Strategy PEEP at maximum 2 cmH2O, if possible 0 cmH2O No recruitment maneuvers Patients are randomized and intra-operatively ventilated with conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers).

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Open abdominal surgery
General anesthesia
High or intermediate risk for postoperative pulmonary complications according to ARISCAT score [J.Canet et al, Anesthesiology 2010;113]

Exclusion Criteria:

Age > 18 years
Body mass index > 40 kg/m2
Laparoscopic surgery
Previous lung surgery (any)
Persistent hemodynamic instability, intractable shock (considered hemodynamic unsuitable for the study by the patient's managing physician)
History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
Recent immunosuppressive medication (receiving chemotherapy or radiation therapy within last 2 months)
Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's)
Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days
Pregnancy (excluded by laboratory analysis)
Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
Neuromuscular disease (any)
Consented for another interventional study or refusal to participate in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441791

Show 30 Study Locations

Sponsors and Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

European Society of Anaesthesiology

Investigators

Principal Investigator:	Marcus J Schultz, MD	Department of Intensive Care, Academic Medical Center, University of Amsterdam
Principal Investigator:	Paolo Pelosi, MD	Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy
Principal Investigator:	Marcelo Gama de Abreu, MD	Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany
Study Director:	Sabrine NT Hemmes, MD	PROVHILO Study Trial Coordinator, Department of Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, The Netherlands

More Information

Additional Information:

PROVHILO website This link exits the ClinicalTrials.gov site

European Society of Anaesthesiology/Research/Studies/PROVHILO section This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Marcus J Schultz, Principal Investigator and Clinical Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:	NCT01441791 History of Changes
Obsolete Identifiers:	NCT01585116
Other Study ID Numbers:	PROVHILO, ISRCTN70332574, NTR(TC=2517)
Study First Received:	September 23, 2011
Last Updated:	May 17, 2013
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

PEEP
Positive end-expiratory pressure
Recruitment maneuver

Open lung approach
Post-operative complications
Open abdominal surgery

Additional relevant MeSH terms:

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013