OLA to Lowest DP in Cardiac Surgery

Lung Collapse Clinical Trial

Official title:

Open-lung Ventilatory Approach With Positive End-expiratory Pressure Titrated to Lowest Driving Pressure in Cardiac Surgery Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03133754
• Other study ID #: DP-PEEP
• Status: Recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: February 2019

Study information

• Verified date: October 2018
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Collapse
• Pulmonary Atelectasis

Intervention

Procedure:
• DP-PEEP
PEEP titration trial for the lowest DP after the alveolar recruitment maneuver
• RM-5
Fixed standard PEEP after the alveolar recruitment maneuver

Locations

Country	Name	City	State
Spain	Carlos Ferrando	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. — View 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. — View Citation

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. — View 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. Epub 2005 Nov 3. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraoperative
Secondary	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)	72 first postoperative hours