Evidence map›Paper›PMID 25927183›Full record

Trial reportTrials2015

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

Carlos Ferrando, Marina Soro, Jaume Canet, Ma Carmen Unzueta, Fernando Suárez, Julián Librero, Salvador Peiró, Alicia Llombart, Carlos Delgado, Irene León and 27 more

6 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
4.8field-weighted citation impact, top 5% 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.

NCT02158923 nacompletednot on this map

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation. A Comparative, Prospective, Multicenter, Randomized Controlled Trial.

TypeinterventionalSponsorFundación para la Investigación del Hospital Clínico de ValenciaRan2014 to 2016Enrolled920ConditionsModerated-high Risk of Postoperative Pulmonary Complication, Abdominal Surgery Expected More Than Two HoursArmsAlveolar recruitment maneuver, Calculation of optimal PEEP, Postoperative CPAP
NCT03133754 naunknown statusnot on this mapstarted 2017, after this paper: background citation

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

TypeinterventionalSponsorFundación para la Investigación del Hospital Clínico de ValenciaRan2017 to 2019Enrolled60ConditionsLung CollapseArmsDP-PEEP, RM-5
NCT03568786 nacompletednot on this mapstarted 2016, after this paper: background citation

Influence of the End-inspiratory Pause on Mechanical Ventilation and Its Correlation With Electrical Impedance Tomography

TypeinterventionalSponsorFundación Pública Andaluza para la gestión de la Investigación en SevillaRan2016 to 2018Enrolled32ConditionsAnesthesia, SurgeryArmsEnd-inspiratory pause 10%, End-inspiratory pause 30%
NCT03937375 completednot on this mapstarted 2019, after this paper: background citation

Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery - An Individual Patient Data Meta-Analysis of PROVHILO, iPROVE and PROBESE

TypeobservationalSponsorHospital Israelita Albert EinsteinRan2019 to 2020Enrolled3,837ConditionsSurgery, Mechanical Ventilation Complication, Pulmonary ComplicationArmsHigh PEEP, Low PEEP
NCT05514366 nacompletednot on this mapstarted 2023, after this paper: background citation

Influence of Inspiratory Pause on Ventilatory Efficiency and Tidal Volume Distribution in Patients Undergoing Robotic Prostate Surgery and Ventilated With an Individualized Open Lung Approach. A Prospective Paired Study.

TypeinterventionalSponsorFundación Pública Andaluza para la gestión de la Investigación en SevillaRan2023 to 2023Enrolled18ConditionsMechanical Ventilation, Positive End-Expiratory Pressure, AnesthesiaArmsModifying EIP under a tOLA before pneumoperitoneum, Modifying EIP under a tOLA with pneumoperitoneum, Atelectasis test
NCT06123039 completednot on this mapstarted 2023, after this paper: background citation

Use of Heart-lung Interaction Parameters to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP During Invasive Mechanical Ventilation in the Operating Room

TypeobservationalSponsorHospital Universitario La FeRan2023 to 2025Enrolled72ConditionsAnesthesia, Perioperative/Postoperative Complications, Hypovolemia, Haemodynamic InstabilityArmsTidal Volume Challenge, Recruitment maneuver obtaining individualised PEEP
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Pathogenesis of ventilator-induced lung injury: metabolomics analysis of the lung and plasma.Metabolomics : Official journal of the Metabolomic Society · 2022
    Article
  11. Observational
  12. Article
  13. Observational
  14. Observational
  15. Article
  16. Review
  17. 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

37 authors at 20 institutions in 3 countries.

Carlos FerrandoAnesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cafeoranestesia@gmail.com.
Marina SoroAnesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. soromarina@gmail.com.
Jaume CanetAnesthesiology and Critical Care Department, Hospital Germans Tries i Pujol, Carretera de Canyet s/n, 08916, Badalona, Spain. jcanet54@gmail.es.
Ma Carmen UnzuetaAnesthesiology and Critical Care Department, Hospital San Pau, Carrer de Sant Quintí, 89, CP: 08026, Barcelona, Spain. mcunzueta@gmail.com.
Fernando SuárezIntensive Care Department, Uppsala University Hospital, Suecia Akademiska Sjukhuset Uppsala University, CP: 75185, Uppsala, Sweden. fsuarez.sipmann@surgsci.uu.se.
Julián LibreroFISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. librero_jul@gva.es.
Salvador PeiróFISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. peiro_bor@gva.es.
Alicia LlombartAnesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. allombart@incliva.es.
Carlos DelgadoAnesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. cardelna@gmail.com.
Irene LeónAnesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. irene.leon.carsi@gmail.com.
Lucas RoviraAnesthesiology and Critical Care Department, Hospital de Manises, Av. De la Generalitat Valenciana, Manises, CP: 46940, Spain. lucasrovira@gmail.com.
Fernando RamascoAnesthesiology and Critical Care Department, Hospital La Princesa of Madrid, Calle de Diego León, 62, CP: 28006, Madrid, Spain. gorria66@gmail.com.
Manuel GranellAnesthesiology and Critical Care Department, Hospital General of Valencia, Av. De les Tres Creus, 2, Valencia, CP: 46014, Spain. mgranellg@gmail.com.
César AldecoaAnesthesiology and Critical Care Department, Hospital Río Hortega of Valladolid, Calle Dulzaina, 2, Valladolid, CP 47012, Spain. cesar.aldecoa@gmail.com.
Oscar DiazAnesthesiology and Critical Care Department, Hospital La Fe of Valencia, Av. De Fernando Abril Martorell, 106, Valencia, CP: 46026, Spain. oscardiazcambronero@gmail.com.
Jaume BalustAnesthesiology and Critical Care Department, Hospital Clínic i Provincial of Barcelona, Carrer Villarroel 170, Barcelona, CP: 08036, Spain. jbalust@clinic.ub.es.
Ignacio GaruttiAnesthesiology and Critical Care Department, Hospital General Gregorio Marañon of Madrid, Calle del Doctor Esquerdo, 46, Madrid, CP: 28007, Spain. ngaruttimartinez@yahoo.es.
Manuel de la MattaAnesthesiology and Critical Care Department, Hospital Vírgen del Rocio of Sevilla, Av. Manuel Siurot s/n, Sevilla, CP: 41013, Spain. mdlmatta@hotmail.com.
Alberto PensadoAnesthesiology and Critical Care Department, Complejo Hospitalario Juan Canalejo of La Coruña, Xubias, 84, La Coruña, CP: 15006, Spain. Teresa.Alonso.Ferreira@sergas.es.
Rafael GonzalezAnesthesiology and Critical Care Department, Hospital of León, C/ Altos de Nava s/n, Leon, CP: 24701, Spain. rafarealeon@gmail.com.
M Eugenia DuránAnesthesiology and Critical Care Department, Hospital Vírgen de la Arraixaca of Murcia, Carretera de Madrid-Cartagena s/n, Madrird, CP: 30120, Spain. geniaduran@gmail.com.
Lucia GallegoAnesthesiology and Critical Care Department, Hospital Miguel Servet of Zaragoza, Paseo Isabel la Católica, 1-3, Zaragoza, CP: 50009, Spain. lgallegoligorit@gmail.com.
Santiago García Del ValleAnesthesiology and Critical Care Department, Hospital Fundación of Alcorcón, Calle de Valdelaguna, 1, Alcorcón, CP: 28922, Spain. sgarcia@anestesiar.org.
Francisco J RedondoAnesthesiology and Critical Care Department, Hospital General of Ciudad Real, C/ Alisos, 19, Ciudad Real, CP: 13002, Spain. ardredondo@hotmail.com.
Pedro DiazAnesthesiology and Critical Care Department, Hospital de Valme of Sevilla, Av. Bellavista s/n, Sevilla, CP: 41014, Spain. d_spedro@hotmail.com.
David PestañaAnesthesiology and Critical Care Department, Hospital Ramón y Cajal of Madrid, Carretera de Colmenar Viejo Km 9, Madrid, CP: 28034, Spain. dpestanalag@hotmail.com.
Aurelio RodríguezAnesthesiology and Critical Care Department, Hospital de Gran Canaria Dr. Negrín, c/ Barranco de la Ballena s/n, Negrin, CP: 35010, Spain. arodperp@gobiernodecanarias.org.
Javier AguirreAnesthesiology and Critical Care Department, Hospital of Galdakano, Barrio Labeaga s/n, Galdakano, CP: 48960, Spain. javier.aguirrearas@osakidetza.net.
Jose M GarcíaAnesthesiology and Critical Care Department, Complejo Hospitalario Juan Ramón Jimenez of Huelva, Ronda exterior norte, s/n, Huelva, CP: 21005, Spain. JMGG1982BOLLU@hotmail.com.
Javier GarcíaAnesthesiology and Critical Care Department, Hospital Puerta de Hierro of Majadahonda, C/ Manuel de Falla, 1, Majadahonda, CP: 28222, Spain. ventilacionanestesia@gmail.com.
Elena EspinosaAnesthesiology and Critical Care Department, Hospital Nuestra Señora de la Candelaria of Santa Cruz de Tenerife, Carretera del Rosario, 145, Santa Cruz de Tenerife, CP: 38010, Spain. mespdom@gmail.com.
Pedro CharcoAnesthesiology and Critical Care Department, Hospital Son Espases of Mallorca, Carretera de la Valldemosa, 79, Mallorca, CP: 07120, Spain. pcharco@gmail.com.
Jose NavarroAnesthesiology and Critical Care Department, Hospital General of Alicante, Pintor Baeza, 12, Alicante, CP: 03010, Spain. jnavarro.martinez@gmail.com.
Clara RodríguezFISABIO salud Pública, Av. Cataluña, 21, CP: 46020, Valencia, Spain. rodriguez_claber@gva.es.
Gerardo TusmanAnesthesiology Department, Hospital Privado de Comunidad Mar de Plata, Mar de Plata, Argentina. gtusman@hotmail.com.
Francisco Javier BeldaAnesthesiology and Critical Care Department, Hospital Clínico of Valencia, Av. Blasco Ibañez, 17, Valencia, CP: 46010, Spain. fco.javier.belda@uv.es.
iPROVE investigators (Appendices 1 and 2)
Hospital Clínico Universitario de Valencia · ESFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · ESHospital General Universitario De Valencia · ESHospital General Universitario Gregorio Marañón · ESHospital San Juan de la Cruz · ESHospital Universitario de Gran Canaria Doctor Negrín · ESHospital Universitario Fundación Alcorcón · ESHospital Universitario Nuestra Señora de Candelaria · ESUppsala University Hospital · SEHospital Clínic de Barcelona · ESHospital de Galdakao · ESHospital de Manises · ESHospital de Sant Pau · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital General Universitario de Ciudad Real · ESHospital Universitario de Valme · ESHospital Universitario Miguel Servet · ESHospital Universitario Puerta de Hierro Majadahonda · ESHospital Universitario Río Hortega · ESHospital Universitario Virgen de la Arrixaca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery.

methodsThis is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. DISCUSSION: The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications.

trial registrationRegistered on 5 June 2014 with identification no. NCT02158923 .

Indexed as

Continuous Positive Airway PressureAbdomenClinical ProtocolsFemaleHumansLungLung DiseasesMalePerioperative CarePostoperative ComplicationsProspective StudiesResearch DesignRespiration, ArtificialSpainTime FactorsTreatment Outcome

Identifiers

PMID25927183
PMCPMC4425893
OpenAlexW2014980969

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.