OLA to Lowest DP in Cardiac Surgery

NCT ID: NCT03133754

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Collapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DP-PEEP

recruitment maneuver + individualized PEEP

Group Type EXPERIMENTAL

DP-PEEP

Intervention Type PROCEDURE

PEEP titration trial for the lowest DP after the alveolar recruitment maneuver

RM-5

recruitment maneuver + fixed standard PEEP

Group Type ACTIVE_COMPARATOR

RM-5

Intervention Type PROCEDURE

Fixed standard PEEP after the alveolar recruitment maneuver

Interventions

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DP-PEEP

PEEP titration trial for the lowest DP after the alveolar recruitment maneuver

Intervention Type PROCEDURE

RM-5

Fixed standard PEEP after the alveolar recruitment maneuver

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role lead

Responsible Party

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Carlos Ferrando

Principal investigador

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carlos Ferrando

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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carlos ferrando, MD, PhD

Role: primary

609892732

References

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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.

Reference Type BACKGROUND
PMID: 28322416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25978326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25927183 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24343688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16271479 (View on PubMed)

Other Identifiers

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DP-PEEP

Identifier Type: -

Identifier Source: org_study_id

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