NCT01441791

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
10 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

September 23, 2011

Last Update Submit

December 7, 2014

Conditions

Postoperative Respiratory Complications

Keywords

PEEPPositive end-expiratory pressureRecruitment maneuverOpen lung approachPost-operative complicationsOpen abdominal surgery

Outcome Measures

Primary Outcomes (1)

  • Post-operative pulmonary complications (PPCs)

    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

    first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up.

Secondary Outcomes (4)

  • Post-operative extra-pulmonary complications

    first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up

  • Intra-operative mechanical ventilation related complications

    during the length of anesthesia, which will be an estimated 2 to 5 hours

  • Unscheduled Intensive Care Unit (ICU) (re-) admission

    first 5 days post-operative and on the day of discharge a final assessment is performed scoring endpoints occuring on day 6 and up

  • Length of hospital stay on day 90

    until day 90 post-operative

Study Arms (2)

Lung protective strategy ventilation

EXPERIMENTAL

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

Conventional Strategy

NO INTERVENTION

* 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).

Interventions

Lung protective strategy ventilationPROCEDURE

Patients are randomized and intra-operatively ventilated with a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers)

Lung protective strategy ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinics

Rochester, New York, 55905, United States

Location

Medical University,

Vienna, Austria

Location

Ziekenhuis Netwerk Antwerpen

Antwerp, Belgium

Location

AZ Sint-Jan

Bruges, Belgium

Location

UZ Gent

Ghent, Belgium

Location

Virga Jesse Hospital

Hasselt, Belgium

Location

Hospital Clínico de la Pontificia Universidad Católica de Chile, Santiago, Chile

Santiago, Chile

Location

University Hospital Sveti Duh

Zagreb, Croatia

Location

University Hospital of Bonn Medical School

Bonn, Germany

Location

University Clinic Carl Gustav Carus, Dresden, Germany

Dresden, Germany

Location

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, Germany

Location

University of Leipzig

Leipzig, Germany

Location

University Medical Center Mainz

Mainz, Germany

Location

Università degli Studi di Catanzaro

Catanzaro, Italy

Location

University of Foggia

Foggia, Italy

Location

Università degli Studi di Genova

Genoa, Italy

Location

Università degli Studi di Napoli Federico II , Napoli, Italy

Napoli, Italy

Location

Università degli Studi di Palermo

Palermo, Italy

Location

Università degli Studi di Roma Cattolica

Rome, Italy

Location

Hospital of Rivoli

Turin, Italy

Location

Università degli Studi di Udine

Udine, Italy

Location

Università degli Studi dell'Insubria

Varese, Italy

Location

Academic Medical Centre

Amsterdam, Netherlands

Location

Fundació Puigvert (IUNA)

Barcelona, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitari Germans Trias I Pujol, Barcelona, Spain

Barcelona, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

Location

Barts Health NHS Trust

London, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Location

Related Publications (5)

  • Hemmes SN, Severgnini P, Jaber S, Canet J, Wrigge H, Hiesmayr M, Tschernko EM, Hollmann MW, Binnekade JM, Hedenstierna G, Putensen C, de Abreu MG, Pelosi P, Schultz MJ. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery. Trials. 2011 May 6;12:111. doi: 10.1186/1745-6215-12-111.

    PMID: 21548927BACKGROUND

  • J. Canet et al, Anesthesiology 2010;113 http://www.ncbi.nlm.nih.gov/pubmed/21045639

    BACKGROUND

  • Serpa Neto A, Bos LD, Campos PPZA, Hemmes SNT, Bluth T, Calfee CS, Ferner M, Guldner A, Hollmann MW, India I, Kiss T, Laufenberg-Feldmann R, Sprung J, Sulemanji D, Unzueta C, Vidal Melo MF, Weingarten TN, Tuip-de Boer AM, Pelosi P, Gama de Abreu M, Schultz MJ; PROVHILO* and the PROVE** investigators. Association between pre-operative biological phenotypes and postoperative pulmonary complications: An unbiased cluster analysis. Eur J Anaesthesiol. 2018 Sep;35(9):702-709. doi: 10.1097/EJA.0000000000000846.

    PMID: 29957706DERIVED

  • Treschan TA, Schaefer M, Kemper J, Bastin B, Kienbaum P, Pannen B, Hemmes SN, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Ventilation with high versus low peep levels during general anaesthesia for open abdominal surgery does not affect postoperative spirometry: A randomised clinical trial. Eur J Anaesthesiol. 2017 Aug;34(8):534-543. doi: 10.1097/EJA.0000000000000626.

    PMID: 28306591DERIVED

  • Serpa Neto A, Campos PP, Hemmes SN, Bos LD, Bluth T, Ferner M, Guldner A, Hollmann MW, India I, Kiss T, Laufenberg-Feldmann R, Sprung J, Sulemanji D, Unzueta C, Melo MF, Weingarten TN, Boer AM, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Kinetics of plasma biomarkers of inflammation and lung injury in surgical patients with or without postoperative pulmonary complications. Eur J Anaesthesiol. 2017 Apr;34(4):229-238. doi: 10.1097/EJA.0000000000000614.

    PMID: 28187051DERIVED

Related Links

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Sabrine NT Hemmes, MD

    PROVHILO Study Trial Coordinator, Department of Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, The Netherlands

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Clinical Professor

Study Record Dates

First Submitted

September 23, 2011

First Posted

September 28, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

NL(1)IT(9)ES(4)US(2)AU(1)BE(4)CL(1)CR(1)DE(5)GB(2)