Driving Pressure During General Anesthesia for Open Abdominal Surgery

Postoperative Respiratory Complication Clinical Trial

— DESIGNATION  

Official title:

Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION) - a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03884543
• Other study ID #: DESIGNATION
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2019
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Sunny Nijbroek, MD
• Phone: +3120-56 62533
• Email: s.g.nijbroek[@]amc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1468
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Respiratory Complication

Intervention

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)

Locations

Country	Name	City	State
Germany	University hospital Carl Gustav Carus	Dresden
Germany	Heinrich-Heine University Hospital Dusseldorf	Dusseldorf
Germany	Bermanntrost BG Klinikum Halle	Halle
Italy	Ospedale Policlinico San Martino	Genua
Italy	University hospital Napoli	Napoli
Netherlands	Noordwest ziekenhuizengroep Alkmaar	Alkmaar
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Amsterdam
Netherlands	Amsterdam UMC location VUmc	Amsterdam
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	HAGA	Den Haag
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Martini Hospital	Groningen
Netherlands	UMC Groningen	Groningen
Netherlands	Spaarne Gasthuis Hospital	Haarlem
Netherlands	Medical Center Leeuwarden	Leeuwarden
Netherlands	Leiden UMC	Leiden
Netherlands	Maastricht UMC	Maastricht
Netherlands	Radboud UMC	Nijmegen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Bernhoven Hospital	Uden

Sponsors (33)

Lead Sponsor

Collaborator

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

Albert Schweitzer Hospital, Alrijne Hospital, Amsterdam UMC, location VUmc, Antoni van Leeuwenhoek Ziekenhuis, Bermanntrost BG Klinikum Halle, Bernhoven Hospital, Campus Bio-Medico University, Erasmus Medical Center, HagaZiekenhuis, Heinrich-Heine University, Duesseldorf, Hospital Universitario La Fe, Isala, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Jeroen Bosch Ziekenhuis, Leiden University Medical Center, Maastricht University Medical Center, Martini Hospital Groningen, Meander Medical Center, Medical Center Haaglanden, Medical Centre Leeuwarden, Medical University Innsbruck, Medisch Spectrum Twente, Noord West Ziekenhuizen location Alkmaar, Onze Lieve Vrouwe Gasthuis, Ospedale Policlinico San Martino, Radboud University Medical Center, Rijnstate Hospital, Spaarne Gasthuis, University Hospital Carl Gustav Carus, University Medical Center Groningen, University of Campania "Luigi Vanvitelli", University of Roma La Sapienza

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands, 

References & Publications (1)

Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants developing one or more postoperative pulmonary complications (PPCs)	Severe respiratory failure; ARDS; Suspected pulmonary infection; Pulmonary infiltrate ; Pleural effusion; Atelectasis; Pneumothorax; Bronchospasm; Aspiration pneumonitis; Cardiopulmonary edema	The first 5 postoperative days
Secondary	Rate of mild respiratory failures	Defined as a PaO2 < 60 mmHg (or < 7.9 kPa) or SpO2 < 90% in room air, but responding to supplemental oxygen (excluding hypoventilation)	The first 5 postoperative days
Secondary	Proportion of participants developing one or more post-operative extra-pulmonary complications	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])	The first 5 postoperative days
Secondary	Rate of intra-operative complications		For the length of the anesthesia, which will be estimated 2 to 5 hours.
Secondary	The total amount and type of intraoperative fluid administration	Type of fluids: colloids, crystalloids or blood products	For the length of the anesthesia, which will be estimated 2 to 5 hours
Secondary	Rate of all-cause mortality and in-hospital mortality		Postoperative day 5, day 30 and day 90
Secondary	Length of hospital stay		From the day of surgery until the day of discharge, up to day 90
Secondary	Number of participants with an unscheduled Intensive Care Unit (ICU) (re-) admission and length of stay in Intensive care unit		From the day of surgery until the day of discharged, up to day 90
Secondary	Assessment of postoperative wound healing	Visual inspection of the following: impairment of wound healing and/or wound infection;	The first 5 postoperative days