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Status unknownNCT03133754Updated Oct 2, 2018

OLA to Lowest DP in Cardiac Surgery

An interventional study of DP-PEEP and RM-5 in Lung Collapse, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Lung Collapse

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03

In context

Pulmonary Atelectasis

301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.

This study's planned enrollment of 60 is close to the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.

Browse Pulmonary Atelectasis studies →

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 70 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Non-obese patients scheduled for cardiac surgery (CABG and valve replacement)

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    DP-PEEP

    recruitment maneuver + individualized PEEP

    Procedure: DP-PEEP

  • Active comparator
    RM-5

    recruitment maneuver + fixed standard PEEP

    Procedure: RM-5

Interventions

  • ProcedureDP-PEEP

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

  • ProcedureRM-5

    Fixed standard PEEP after the alveolar recruitment maneuver

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What researchers measure

Primary outcomes

  1. 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

    Time frame: intraoperative

Secondary outcomes

  1. 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)

    Time frame: 72 first postoperative hours

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 28322416 ↗
  • 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. PubMed 25978326 ↗
  • 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. PubMed 25927183 ↗
  • 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. PubMed 24343688 ↗
  • 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. PubMed 16271479 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03133754
Lead sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Responsible party
Carlos Ferrando (Principal investigador, Fundación para la Investigación del Hospital Clínico de Valencia) — Principal investigator
First posted
Apr 28, 2017
Start date
Jul 10, 2017
Primary completion
Dec 2018 (estimated)
Completion
Feb 2019 (estimated)
Last update
Oct 2, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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