OLA to Lowest DP in Cardiac Surgery
Primary Purpose
Lung Collapse
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DP-PEEP
RM-5
Sponsored by
About this trial
This is an interventional treatment trial for Lung Collapse
Eligibility Criteria
Inclusion Criteria:
- Non-obese patients scheduled for cardiac surgery (CABG and valve replacement)
Exclusion Criteria:
- i) age <18yr or >80yr, ii) pregnancy or breast-feeding status, and iii) patients with previous known respiratory disease, iv) Body mass index >35 kg/m2, v) emergency surgery and vi) hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device.
Sites / Locations
- Carlos FerrandoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DP-PEEP
RM-5
Arm Description
recruitment maneuver + individualized PEEP
recruitment maneuver + fixed standard PEEP
Outcomes
Primary Outcome Measures
driving pressure
The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications
Secondary Outcome Measures
Postoperative pulmonary complications
The most frequent postoperative pulmonary complications will be recorded (acute respiratory failure, pneumonia, atelectasis, need of ventilatory support, acute respiratory distress syndrome)
Full Information
NCT ID
NCT03133754
First Posted
April 25, 2017
Last Updated
October 1, 2018
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
1. Study Identification
Unique Protocol Identification Number
NCT03133754
Brief Title
OLA to Lowest DP in Cardiac Surgery
Official Title
Open-lung Ventilatory Approach With Positive End-expiratory Pressure Titrated to Lowest Driving Pressure in Cardiac Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compared the effects in driving pressure of an open-lung strategy with a positive end-expiratory pressure (PEEP) titrated to best driving pressure (DP) after a RM versus the recommended protective PEEP of 5 cmH2O without a recruitment manuever in non-obese patients undergoing cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Collapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DP-PEEP
Arm Type
Experimental
Arm Description
recruitment maneuver + individualized PEEP
Arm Title
RM-5
Arm Type
Active Comparator
Arm Description
recruitment maneuver + fixed standard PEEP
Intervention Type
Procedure
Intervention Name(s)
DP-PEEP
Intervention Description
PEEP titration trial for the lowest DP after the alveolar recruitment maneuver
Intervention Type
Procedure
Intervention Name(s)
RM-5
Intervention Description
Fixed standard PEEP after the alveolar recruitment maneuver
Primary Outcome Measure Information:
Title
driving pressure
Description
The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Postoperative pulmonary complications
Description
The most frequent postoperative pulmonary complications will be recorded (acute respiratory failure, pneumonia, atelectasis, need of ventilatory support, acute respiratory distress syndrome)
Time Frame
72 first postoperative hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-obese patients scheduled for cardiac surgery (CABG and valve replacement)
Exclusion Criteria:
i) age <18yr or >80yr, ii) pregnancy or breast-feeding status, and iii) patients with previous known respiratory disease, iv) Body mass index >35 kg/m2, v) emergency surgery and vi) hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device.
Facility Information:
Facility Name
Carlos Ferrando
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
carlos ferrando, MD, PhD
Phone
609892732
Email
cafeoranestesia@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
28322416
Citation
Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.
Results Reference
background
PubMed Identifier
25978326
Citation
Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.
Results Reference
background
PubMed Identifier
25927183
Citation
Ferrando C, Soro M, Canet J, Unzueta MC, Suarez F, Librero J, Peiro S, Llombart A, Delgado C, Leon I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Duran ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestana D, Rodriguez A, Aguirre J, Garcia JM, Garcia J, Espinosa E, Charco P, Navarro J, Rodriguez C, Tusman G, Belda FJ; iPROVE investigators (Appendices 1 and 2). Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial. Trials. 2015 Apr 27;16:193. doi: 10.1186/s13063-015-0694-1.
Results Reference
background
PubMed Identifier
24343688
Citation
Borges DL, Nina VJ, Costa Mde A, Baldez TE, Santos NP, Lima IM, Figueredo ED, Lula JL. Effects of different PEEP levels on respiratory mechanics and oxygenation after coronary artery bypass grafting. Rev Bras Cir Cardiovasc. 2013 Jul-Sep;28(3):380-5. doi: 10.5935/1678-9741.20130058.
Results Reference
background
PubMed Identifier
16271479
Citation
Reis Miranda D, Gommers D, Struijs A, Dekker R, Mekel J, Feelders R, Lachmann B, Bogers AJ. Ventilation according to the open lung concept attenuates pulmonary inflammatory response in cardiac surgery. Eur J Cardiothorac Surg. 2005 Dec;28(6):889-95. doi: 10.1016/j.ejcts.2005.10.007. Epub 2005 Nov 3.
Results Reference
background
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OLA to Lowest DP in Cardiac Surgery
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