Evidence map›Paper›PMID 30477541›Full record

ArticleTrials2018

Positive end-expiratory pressure (PEEP) level to prevent expiratory flow limitation during cardiac surgery: study protocol for a randomized clinical trial (EFLcore study).

Elena Bignami, Savino Spadaro, Francesco Saglietti, Antonio Di Lullo, Francesca Dalla Corte, Marcello Guarnieri, Giulio de Simone, Ilaria Giambuzzi, Alberto Zangrillo, Carlo Alberto Volta

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02633423 (Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 76% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02633423 naunknown statusnot on this map

Expiratory Flow Limitation and Mechanical Ventilation During Cardiopulmonary Bypass in Cardiac Surgery

TypeinterventionalSponsorOspedale San RaffaeleRan2018 to 2019Enrolled204ConditionsMitral Regurgitation, Aortic RegurgitationArmsUse of PEEP before and after CPB, No use of PEEP before and after CPB(ZEEP), Ventilation with CPAP during CPB, No ventilation during CPB
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Elena BignamiDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy. elenagiovanna.bignami@unipr.it.
Savino SpadaroDepartment of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Via Aldo Moro 8, 44121, Ferrara, Italy.
Francesco SagliettiDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Antonio Di LulloDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Francesca Dalla CorteDepartment of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Via Aldo Moro 8, 44121, Ferrara, Italy.
Marcello GuarnieriDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Giulio de SimoneDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Ilaria GiambuzziDepartment of Cardiac Surgery, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Alberto ZangrilloDepartment of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Carlo Alberto VoltaDepartment of Morphology, Surgery and Experimental Medicine, Section of Anesthesia and Intensive Care, University of Ferrara, Via Aldo Moro 8, 44121, Ferrara, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITIstituto di Ricovero e Cura a Carattere Scientifico San RaffaeleUniversity of Ferrara · ITVita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLung dysfunction commonly occurs after cardiopulmonary bypass (CPB). Randomized evidence suggests that the presence of expiratory flow limitation (EFL) in major abdominal surgery is associated with postoperative pulmonary complications. Appropriate lung recruitment and a correctly set positive end-expiratory pressure (PEEP) level may prevent EFL. According to the available data in the literature, an adequate ventilation strategy during cardiac surgery is not provided. The aim of this study is to assess whether a mechanical ventilation strategy based on optimal lung recruitment with a best PEEP before and after CPB and with a continuous positive airway pressure (CPAP) during CPB would reduce the incidence of respiratory complications after cardiac surgery. METHODS/

designThis will be a single-center, single-blind, parallel-group, randomized controlled trial. Using a 2-by-2 factorial design, high-risk adult patients undergoing elective cardiac surgery will be randomly assigned to receive either a best PEEP (calculated with a PEEP test) or zero PEEP before and after CPB and CPAP (equal to the best PEEP) or no ventilation (patient disconnected from the circuit) during CPB. The primary endpoint will be a composite endpoint of the incidence of EFL after the weaning from CPB and postoperative pulmonary complications. DISCUSSION: This study will help to establish a correct ventilatory strategy before, after, and during CPB. The main purpose is to establish if a ventilation based on a simple and feasible respiratory test may preserve lung function in cardiac surgery.

trial registrationClinicalTrials.gov, ID: NCT02633423 . Registered on 6 December 2017.

Indexed as

Cardiac Surgical ProceduresCardiopulmonary BypassContinuous Positive Airway PressurePositive-Pressure RespirationRespirationElective Surgical ProceduresHumansItalyLungLung DiseasesRandomized Controlled Trials as TopicSingle-Blind MethodTime FactorsTreatment OutcomeProtective ventilation, Cardiopulmonary bypass, Respiratory failure, Low tidal volume, Continuous positive airway pressure, Postoperative pulmonary complications

Identifiers

PMID30477541
PMCPMC6258414
OpenAlexW2903334150

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.