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Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884543
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
VU University Medical Center
Noord West Ziekenhuizen location Alkmaar
University Medical Center Groningen
Radboud University
HagaZiekenhuis
Rijnstate Hospital
Medical Center Haaglanden
Bernhoven Hospital
Onze Lieve Vrouwe Gasthuis
Albert Schweitzer Hospital
Medical Centre Leeuwarden
Leiden University Medical Center
Maastricht University Medical Center
Martini Hospital Groningen
Erasmus Medical Center
Spaarne Gasthuis
University Hospital Carl Gustav Carus
Bermanntrost BG Klinikum Halle
Heinrich-Heine University, Duesseldorf
Ospedale Policlinico San Martino
Federico II University
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high PEEP strategy, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications.

Condition or disease Intervention/treatment Phase
Postoperative Respiratory Complication Procedure: Individualized high PEEP strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Individualized high PEEP strategy
Recruitment maneuver (performed after induction of anesthesia, after any disconnection from the mechanical ventilator, and before extubation) followed by the decremental PEEP trial to determine the highest level of PEEP resulting in the lowest driving pressure. This is again followed by a recruitment maneuver, after which PEEP is set at the level indicated by the decremental PEEP trial.
Procedure: Individualized high PEEP strategy
Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)

No Intervention: Standard low PEEP strategy
PEEP at maximum 5cm H2O. No recruitment maneuvers. Patients are randomized and intraoperatively ventilated with conventional strategy. (PEEP at maximum 5cm H2O without recruitment maneuvers)



Primary Outcome Measures :
  1. Proportion of participants developing one or more postoperative pulmonary complications (PPCs) [ Time Frame: The first 5 postoperative days ]
    Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema


Secondary Outcome Measures :
  1. Rate of mild respiratory failures [ Time Frame: The first 5 postoperative days ]
    Defined as a PaO2 < 60 mmHg (or < 7.9 kPa) or SpO2 < 90% in room air, but responding to supplemental oxygen (excluding hypoventilation)

  2. Proportion of participants developing one or more post-operative extra-pulmonary complications [ Time Frame: The first 5 postoperative days ]
    Including sepsis (according to the SEPSIS-3 definition), septic shock (defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥ 65mmHg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation), extra-pulmonary infection (including wound infection and any other infection), anastomic leak and acute renal failure (as defined by AKIN [Mehta RL., et al., Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care, 2007])

  3. Rate of intra-operative complications [ Time Frame: For the length of the anesthesia, which will be estimated 2 to 5 hours. ]
  4. The total amount and type of intraoperative fluid administration [ Time Frame: For the length of the anesthesia, which will be estimated 2 to 5 hours ]
    Type of fluids: colloids, crystalloids or blood products

  5. Rate of all-cause mortality and in-hospital mortality [ Time Frame: Postoperative day 5, day 30 and day 90 ]
  6. Length of hospital stay [ Time Frame: From the day of surgery until the day of discharge, up to day 90 ]
  7. Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit [ Time Frame: From the day of surgery until the day of discharged, up to day 90 ]
  8. Assessment of postoperative wound healing [ Time Frame: The first 5 postoperative days ]
    Visual inspection of the following: impairment of wound healing and/or wound infection;



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Laparoscopic surgery
  • Surgery in prone or lateral position
  • Combined procedure with open abdominal and intrathoracic surgery
  • Body mass index > 40 kg/m2;
  • Reported pregnancy;
  • Mechanical ventilation > than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days;
  • Any major previous lung surgery;
  • History of previous severe chronic obstructive pulmonary disease (COPD) GOLD III or IV, or with (noninvasive) ventilation and/or oxygen therapy at home;
  • (previous) acute respiratory distress syndrome (ARDS);
  • Expected to require postoperative mechanical ventilation;
  • Persistent hemodynamic instability or intractable shock;
  • Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's);
  • Consented for another interventional study during anesthesia or refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884543


Contacts
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Contact: Sunny Nijbroek, MD +3120-56 62533 s.g.nijbroek@amc.nl
Contact: Liselotte Hol, MD +3120-56 62533 l.hol@amc.nl

Locations
Show Show 22 study locations
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University Medical Center
Noord West Ziekenhuizen location Alkmaar
University Medical Center Groningen
Radboud University
HagaZiekenhuis
Rijnstate Hospital
Medical Center Haaglanden
Bernhoven Hospital
Onze Lieve Vrouwe Gasthuis
Albert Schweitzer Hospital
Medical Centre Leeuwarden
Leiden University Medical Center
Maastricht University Medical Center
Martini Hospital Groningen
Erasmus Medical Center
Spaarne Gasthuis
University Hospital Carl Gustav Carus
Bermanntrost BG Klinikum Halle
Heinrich-Heine University, Duesseldorf
Ospedale Policlinico San Martino
Federico II University
Investigators
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Principal Investigator: Marcus J. Schultz, MD PhD Department of Intensive Care
Principal Investigator: Markus W. Hollmann, MD PhD Department of Anesthesiology
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Marcus J. Schultz, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03884543    
Other Study ID Numbers: DESIGNATION
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Mechanical ventilation
Positive end-expiratory pressure
Driving pressure
Post-operative postoperative complications
Open abdominal surgery
Recruitment maneuver
PEEP