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Trial record 2 of 257 for:    Recruiting, Not yet recruiting, Available Studies | "Respiratory Insufficiency"

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA)

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ClinicalTrials.gov Identifier: NCT03145974
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
Asociación Científica Pulmón y Ventilación Mecánica
Consorcio Centro de Investigación Biomédica en Red, M.P.
Information provided by (Responsible Party):
Jesus Villar, Dr. Negrin University Hospital

Brief Summary:

This study is an extension of the Spanish Initiative for Epidemiology, Stratification and Therapies of Acute respiratory failure (SIESTA) Network.

The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure [defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more, and FiO2 of 0.3 or more] admitted in a network of Spanish hospitals.


Condition or disease Intervention/treatment
Acute Respiratory Insufficiency Device: mechanical ventilation

Detailed Description:

The present study is aimed to establish the epidemiological characteristics and clinical outcomes of adult mechanically ventilated patients with acute hypoxemic respiratory failure [defined as a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more] admitted in a network of Spanish hospitals. Although there are few previous published observational studies examining the incidence and mortality of patients with acute respiratory failure and ARDS, there are no studies specifically assessing the epidemiological characteristics, patterns of ventilation and clinical outcomes in patients with acute hypoxemic respiratory failure in the current era of lung protective ventilation.

Since the study is prospective, with consecutive collection of clinically relevant data from patients and with the participation of several ICUs from different geographical regions of Spain, the findings would be highly generalizable. The study is aimed to improve the knowledge on the epidemiology and outcome of ventilated patients, to identify the percentage of patients developing ARDS under the current definition, to validate a bedside scoring system developed by us for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA Study)
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Hypoxemic Acute Respiratory Failure
Consecutive intubated patients receiving invasive mechanical ventilation, with a PaO2/FiO2 ≤300 mmHg under a PEEP of 5 cmH2O or more, and with a FiO2 of 0.3 or more.
Device: mechanical ventilation
ventilatory support



Primary Outcome Measures :
  1. Prevalence of hypoxemic acute respiratory failure [ Time Frame: 6 months ]
    The investigators will calculate the prevalence in relation to: (i) total number of ICU admissions during the study period in all participating centers; (ii) total number of mechanically ventilated patients during the study period in all participating centers, and (iii) per ICU bed available in the participating centers over the study period.


Secondary Outcome Measures :
  1. death in the hospital [ Time Frame: Hospital stay [Maximum 6 months] ]
    outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients admitted to participating ICUs will be screened daily. Only patients meeting inclusion criteria for acute hypoxemic respiratory failure (as defined above) will be enrolled into the study.
Criteria

Inclusion Criteria:

  • Age ≥18-year old.
  • Endotracheal intubation and mechanical ventilation, independent of whether the need for ventilatory support is shorter or longer than 24 hours. Only patients receiving invasive mechanical ventilation can be included, although patients could have been on non-invasive ventilation before intubation.
  • PaO2/FiO2 ≤300 mmHg on invasive mechanical ventilation with a PEEP of 5 cmH2O or more, and with a FiO2 of 0.3 or more.

Exclusion Criteria:

  • No patients should be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145974


Contacts
Contact: Jesús Villar, MD. PhD +34928449413 jesus.villar54@gmail.com
Contact: Rosa L Fernández, MSc +34928450082 rosalidia.fernandez@gmail.com

Locations
Spain
Complejo Hospitalario de Santiago Recruiting
Santiago de Compostela, A Coruña, Spain
Contact: Cristina Domínguez-Antelo, MD    +34600045650    cristinadominguezantelo@hotmail.com   
Hospital Universitario Mutua de Terrasa Recruiting
Terrassa, Barcelona, Spain
Contact: Mar Fernández, MD    +34654027970    marufaes@yahoo.es   
Hospital La Mancha Centro Recruiting
Alcázar de San Juan, Ciudad Real, Spain
Contact: Carmen Martín-Delgado, MD    +34628024856    macarmenmd@sescam.jccm.es   
Hospital El Bierzo Recruiting
Ponferrada, León, Spain
Contact: Eleuterio Merayo, MD    +34619906005    emerayom@gmail.com   
Sub-Investigator: Chanel Martinez, MD         
Hospital Universitario NS de Candelaria Recruiting
Santa Cruz de Tenerife, Tenerife, Spain
Contact: Raquel Montiel, MD    +34617749631    raquelmontiel@gmail.com   
Sub-Investigator: Dacil Parrilla, MD         
Hospital NS del Prado Recruiting
Talavera de la Reina, Toledo, Spain
Contact: Francisco Alba, MD    +34687823357    pacoalbagarcia@hotmail.com   
Contact: Ruth Corpas, MD    +34925803600    ruth_corpas@yahoo.es   
Hospital Universitario de La Coruña Recruiting
A Coruña, Spain
Contact: Fernando Mosteiro, MD    +34600264508    fernando.mosteiro.pereira@sergas.es   
Contact: Lidia Pita-García, MD    +34615459500    Lidia.pita.garcia@sergas.es   
Complejo Hospitalario de Albacete Recruiting
Albacete, Spain
Contact: Isabel Murcia, MD    +34609212303    murciasaez.im@gmail.com   
Contact: Ángel E Pereyra-Pache, MD    +34651472124    angelenriquepp@hotmail.com   
Hospital General de Ciudad Real Recruiting
Ciudad Real, Spain
Contact: Alfonso Ambrós, MD    +34696544641    alfonsoa@sescam.jccm.es   
Sub-Investigator: Ana Bueno-González, MD         
Hospital Virgen de La Luz Recruiting
Cuenca, Spain
Contact: Elena González, MD    +34669900472    elena03gon@gmail.com   
Sub-Investigator: Rosario Solano, MD         
Complejo Hospitalario Universitario de León Recruiting
León, Spain
Contact: Demetrio Carriedo, MD    +34669342578    dcarriedo@saludcastillayleon.es   
Contact: Francisco J Díaz, MD    +34679195052    fjdmowi@hotmail.com   
Hospital Fundación Jiménez Díaz Recruiting
Madrid, Spain
Contact: Anxela Vidal, MD    +34680713669    anxelavidal@gmail.com   
Contact: Denis Robaglia, MD    +34657494002    drobaglia@gmail.com   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Contact: Isidro Prieto, MD    +34667762133    isidroprieto69@gmail.com   
Contact: Mario Chico    +34679328904    murgchico@yahoo.es   
Hospital Universitario La Paz Recruiting
Madrid, Spain
Contact: José M Añón, MD    +34620152794    jmaelizalde@gmail.com   
Sub-Investigator: Mónica Hernández, MD         
Sub-Investigator: Belén Civantos, MD         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain
Contact: Miguel A Romera, MD    +34639420622    miguelangel.romera@gmail.com   
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain
Contact: David Pestaña, MD    +34609353414    dpestanalag@hotmail.com   
Sub-Investigator: Pilar Cobeta, MD         
Sub-Investigator: Adrián Mira, MD         
Hospital Universitario Virgen de Arrixaca Recruiting
Murcia, Spain
Contact: Domingo Martínez, MD    +34968369500    dmbct1@gmail.com   
Contact: Juan A Soler, MD    +34661764387    juasobar@hotmail.com   
Hospital Universitario Carlos Haya Recruiting
Málaga, Spain
Contact: Juan M Mora-Ordoñez, MD    +34666940647    jumouci@gmail.com   
Hospital General de Segovia Recruiting
Segovia, Spain
Contact: Alec Tallet, MD    +34679327684    alectaes@me.com   
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain
Contact: Carlos Ferrando, MD    +34609892732    cafeoranestesia@gmail.com   
Contact: Marina Soro, MD    +34659583815    soromarina@gmail.com   
Sub-Investigator: Javier Belda, MD         
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain
Contact: David Andaluz, MD    +34653432757    dandaluz@saludcastillayleon.es   
Contact: Laura Parra, MD    +34652039780    lavriparra@hotmail.com   
Sub-Investigator: Leonor Nogales, MD         
Hospital Universitario Rio Hortega - Anesthesia Recruiting
Valladolid, Spain
Contact: César Aldecoa, MD    +34657500031    cesar.aldecoa@gmail.com   
Contact: Jesús Rico, MD    +34609024076    jricofe@saludcastillayleon.es   
Hospital Universitario Rio Hortega Recruiting
Valladolid, Spain
Contact: Jesús Blanco, MD    +34615240496    jblancov@saludcastillayleon.es   
Contact: Lorena Fernandez, MD    +34626479670    mlorefer@yahoo.es   
Hospital Virgen de la Concha Recruiting
Zamora, Spain
Contact: Concepción Tarancón, MD    +34609591652    fcontama@yahoo.es   
Contact: Silvia Cortés-Díaz, MD    +34616290921    silviamcortesdiaz@hotmail.com   
Sponsors and Collaborators
Dr. Negrin University Hospital
Asociación Científica Pulmón y Ventilación Mecánica
Consorcio Centro de Investigación Biomédica en Red, M.P.
Investigators
Principal Investigator: Jesús Villar, MD, PhD Hospital Dr. Negrin, Las Palmas de Gran Canaria, Spain

Responsible Party: Jesus Villar, Clinical scientist, Dr. Negrin University Hospital
ClinicalTrials.gov Identifier: NCT03145974     History of Changes
Other Study ID Numbers: ACPVM170501
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patients' data will be anonymized and recorded in a case report form (CRF) specifically designed for this study. Data will be presented globally at the end of the study

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jesus Villar, Dr. Negrin University Hospital:
respiratory failure
mechanical ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases