OLA to Lowest DP in Cardiac Surgery
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia (Other)
Overall Status
Unknown status
CT.gov ID
NCT03133754
Collaborator
(none)
60
1
2
18.8
3.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Open-lung Ventilatory Approach With Positive End-expiratory Pressure Titrated to Lowest Driving Pressure in Cardiac Surgery Patients
Actual Study Start Date
:
Jul 10, 2017
Anticipated Primary Completion Date
:
Dec 1, 2018
Anticipated Study Completion Date
:
Feb 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DP-PEEP recruitment maneuver + individualized PEEP |
Procedure: DP-PEEP
PEEP titration trial for the lowest DP after the alveolar recruitment maneuver
|
| Active Comparator: RM-5 recruitment maneuver + fixed standard PEEP |
Procedure: RM-5
Fixed standard PEEP after the alveolar recruitment maneuver
|
Outcome Measures
Primary Outcome Measures
- driving pressure [intraoperative]
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 [72 first postoperative hours]
The most frequent postoperative pulmonary complications will be recorded (acute respiratory failure, pneumonia, atelectasis, need of ventilatory support, acute respiratory distress syndrome)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Non-obese patients scheduled for cardiac surgery (CABG and valve replacement)
Exclusion Criteria:
-
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carlos Ferrando | Valencia | Spain | 46010 |
Sponsors and Collaborators
- Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Borges DL, Nina VJ, Costa Mde A, Baldez TE, Santos NP, Lima IM, Figuerêdo 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.
- 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.
- Ferrando C, Soro M, Canet J, Unzueta MC, Suárez F, Librero J, Peiró S, Llombart A, Delgado C, León I, Rovira L, Ramasco F, Granell M, Aldecoa C, Diaz O, Balust J, Garutti I, de la Matta M, Pensado A, Gonzalez R, Durán ME, Gallego L, Del Valle SG, Redondo FJ, Diaz P, Pestaña D, Rodríguez A, Aguirre J, García JM, García J, Espinosa E, Charco P, Navarro J, Rodríguez 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.
- 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. Epub 2005 Nov 3.
- 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. Review.
Responsible Party:
Carlos Ferrando,
Principal investigador,
Fundación para la Investigación del Hospital Clínico de Valencia
ClinicalTrials.gov Identifier:
NCT03133754
Other Study ID Numbers:
- DP-PEEP
First Posted:
Apr 28, 2017
Last Update Posted:
Oct 2, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: