Evidence map›Paper›PMID 30157955›Full record

ArticleTrials2018

Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial.

Tommaso Mauri, Giuseppe Foti, Carla Fornari, Jean-Michel Constantin, Claude Guerin, Paolo Pelosi, Marco Ranieri, Sara Conti, Daniela Tubiolo, Egle Rondelli and 15 more

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 NCT03201263 (PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 42% 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.

NCT03201263 nacompletednot on this map

PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial

TypeinterventionalSponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoRan2017 to 2019Enrolled258ConditionsRespiratory Failure, Acute Respiratory Distress Syndrome, Ventilator LungArmsSigh, Standard of care
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
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

25 authors at 12 institutions in 6 countries.

Tommaso MauriFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Giuseppe FotiASST Monza, University of Milan-Bicocca, Monza, Italy.
Carla FornariResearch Centre on Public Health, School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.
Jean-Michel ConstantinDepartment of Preoperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.
Claude GuerinService de Réanimation Médicale, Hôpital de la Croix Rousse, Lyon, France.
Paolo PelosiDepartment of Surgical and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy.
Marco RanieriDepartment of Anesthesia and Intensive Care Medicine, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy.
Sara ContiResearch Centre on Public Health, School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy.
Daniela TubioloFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Egle RondelliASST Monza, University of Milan-Bicocca, Monza, Italy.
Federica LovisariDepartment of Anesthesia and Critical Care, Niguarda Hospital, University of Milan-Bicocca, Milan, Italy.
Tommaso FossaliDepartment of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco - Luigi Sacco Hospital, Milan, Italy.
Savino SpadaroDepartment of morphology, surgery and experimental medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant'Anna, Ferrara, Italy.
Domenico Luca GriecoDepartment of Anesthesiology and Intensive Care Medicine, Catholic University of The Sacred Heart, IRCCS Fondazione Policlinico A. Gemelli, Rome, Italy.
Paolo NavalesiDipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia di Catanzaro, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro, Italy.
Italo CalamaiAUSL Toscana Centro, Unit of Anesthesia and Resuscitation, San Giuseppe Hospital, Empoli, Italy.
Tobias BecherDepartment of Anesthesiology and Intensive Care Medicine, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Oriol RocaCritical Care Department, Vall d'Hebron University Hospital, Vall d'Hebron Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.
Yu-Mei WangDepartment of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Rihard KnafeljCenter for Internal Intensive medicine (MICU), University Medical Center Ljubljana, Ljubljana, Slovenia.
Andrea CortegianiDepartment of Biopathology and Medical Biotechnologies (DIBIMED), Section of Anesthesia, Analgesia, Intensive Care and Emergency, Policlinico Paolo Giaccone, University of Palermo, Palermo, Italy.
Jordi ManceboServei de Medicina Intensiva, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
Laurent BrochardInterdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.
Antonio PesentiFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. antonio.pesenti@unimi.it.ORCID http://orcid.org/0000-0003-2593-729X
Protection Study Group
University of Milan · ITUniversitat Autònoma de Barcelona · ESUniversity of Milano-Bicocca · ITAzienda Ospedaliero Universitario Mater Domini · ITHôpital de la Croix-Rousse · FRLuigi Sacco Hospital · ITPoliclinico Umberto I · ITArcispedale Sant'Anna · ITCapital Medical University · CNLjubljana University Medical Centre · SIOspedale San Giuseppe · ITSt. Michael's Hospital · CA

Funding

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico RC-2018
6 · The paper itself

Abstract

backgroundAdding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study).

methodsPROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and undergoing PSV from 4 to 24 h will be enrolled. All patients will first undergo a 30-min sigh test by adding sigh to clinical PSV for 30 min to identify early oxygenation responders. Then, patients will be randomized to PSV or PSV + sigh until extubation, ICU discharge, death or day 28. Sigh will be delivered as a 3-s pressure control breath delivered once per minute at 30 cmH DISCUSSION: PROTECTION is a pilot randomized controlled trial testing the feasibility of adding sigh to PSV. If positive, it will provide physicians with an effective addition to standard PSV for lung protection, able to reduce failure of assisted ventilation. PROTECTION will provide the basis for a future larger trial aimed at verifying the impact of PSV + sigh on 28-day survival and ventilator-free days.

trial registrationClinicalTrials.gov, NCT03201263 . Registered on 28 June 2017.

Indexed as

Randomized Controlled Trials as TopicFeasibility StudiesHumansHypoxiaIntubation, IntratrachealLungMulticenter Studies as TopicPilot ProjectsPositive-Pressure RespirationRecovery of FunctionRespiratory InsufficiencyTime FactorsTreatment OutcomeIntervention studyMechanical ventilationPositive-pressure ventilationPressure supportRecruitmentSighVentilator-induced lung injuryWeaning

Identifiers

PMID30157955
PMCPMC6114230
OpenAlexW2888882658

What OpenQuestion holds

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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.