Acute Respiratory InsufficiencyPANDORA-childNCT04791501
Prevalence AND Outcome of Acute Hypoxemic Respiratory fAilure in CHILDren (PANDORA-CHILD)
An observational study of Acute Respiratory Insufficiency, run by Yolanda Lopez Fernandez at 23 sites in Spain.
Trial summary
The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated children with acute hypoxemic respiratory failure (AHRF), defined as PaO2/FiO2 ≤300 mmHg on PEEP≥5 cmH2O and FiO2≥0.3, admitted in a network of pediatric hospitals in Spain. Read more about this study
- Who is it for?
- Ages 7 days to 16 years
- Conditions the study is for
- Acute Respiratory Insufficiency
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 23 sitesSpain
- Study dates
- 1 Oct 2019to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All consecutive patients from 7 days to 16 years old admitted in the PICU with an acute episode (within 7 days of a clinical insult) of hipoxemia defined as PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), and on invasive mechaniccal ventilatio with a PEEP ≥ 5 cmH2O and FiO2 ≥ 0.3.
Who may be able to join
- Patients from 7 days to 16 years old admitted in the PICU.
- Acute episode (within 7 days of a clinical insult)
- On invasive mechanical ventilatory support
- PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264)
- Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.
Who cannot join
- Non-invasive respiratory support *Aged >16 years or < 7 days.
Trial locations and contacts
23 sites in 1 country.
Yolanda M López-Fernández, MD contact
23 sites in 1 country
Spain23 sites, 23 recruiting
- Recruiting
Cruces University Hospital
Barakaldo, Bizkaia, 48903
Yolanda M López-Fernández, MD, 0034946000000 ext. 6582, yolandamarg.lopezfernandez@osakidetza.eus
Yolanda M Lopez Fernandez, MD
- Recruiting
Hospital Universitario
Burgos
María González, MD, lapuris@hotmail.com
María García, MD
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
Patricia Rodriguez, p.r.campoy@gmail.com
Patricia Rodriguez, MD
- Recruiting
Hospital Universitario Reina Sofia
Córdoba
Ignacio Ibarra, MD, igibarrarosa@gmail.com
Ignacio Ibarra, MD
- Recruiting
Complejo Hospitalario Donosti
Donostia / San Sebastian, Gipuzkoa
Eider Oñate, eider.oñatevergara@osakidetza.eus
Eider Oñate, MD, PhD
- Recruiting
Hospital Universitario
Las Palmas de Gran Canaria
Rocio Nuñez, MD, rocio.nuñez.borrero@gmail.com
Rocio Nuñez, MD
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Juan I Sanchez, MD, juanigancio.sanchez@madrid.salud.org
Juan I Sanchez, MD
- Recruiting
Hospital Universitario Gregorio Marañón
Madrid
Laura Herrera, MD, laura.herreracastillo@gmail.com
Laura Herrera, MD
- Recruiting
Hospital Universitario La Paz
Madrid
Ana Gomez Zamora, MD, agzamora77@gmail.com
Ana Gomez Zamora, MD
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Ana Coca, MD, pdacoca@gmail.com
Ana Coca, MD
- Recruiting
Hospital Universitario Virgen de la Arrixaca
Madrid
Susana B Reyes, MD, PhD, susanareyes.3110@gmail.com
Susana B Reyes, MD, PhD
- Recruiting
Niño Jesús University Hospital
Madrid
Amelia Martínez de Azagra, MD, ameliamartinezdeazagra@gmail.com
Amelia Martinez de Azagra, MD
- Recruiting
Hospital Universitario
Málaga
Jose M Gonzalez, josemagogo@hotmail.com
Jose M Gonzalez, MD
- Recruiting
Hospital Central de Asturias
Oviedo
Alberto Medina, MD, PhD, amedinavillanueva@gmail.com
Alberto Medina, MD, PhD
- Recruiting
Hospital Universitario Virgen del Camino
Pamplona
Mikel Mendizabal, MD, mmendizabaldiez@gmail.com
Mikel Mendizabal, MD
- Recruiting
Hospital Universitario de Salamanca
Salamanca
Francisco Fernández, MD, pacojum@gmail.com
Francisco Fernández, MD
- Recruiting
Hospital Universitario Tenerife
Santa Cruz de Tenerife
Luis Perez, luisperbae@gmail.com
Luis Perez, MD
- Recruiting
Hospital Universitario Santiago de Compostela
Santiago de Compostela
Antonio Rodriguez, MD, antonio.rodruiguez.nuñez@sergas.es
Antonio Rodriguez, MD, PhD
- Recruiting
Hospital Universitario Virgen del Rocio
Seville
Julio Parrilla, MD, julioparril@hotmail.com
Julio Parrilla, MD
- Recruiting
Hospital Universitario Virgen de la Salud
Toledo
David Arjona, MD, daroja@sescam.jccm.es
David Arjona
- Not yet recruiting
Hospital Universitario La fe
Valencia
Vicent Modesto, vicent.modesto@gmail.com
Vicent Modesto, MD, PhD
- Recruiting
Hospital Clinico Universitario
Valladolid
Marta Brezmes, martabrezmes@hotmail.com
Marta Brezmes, MD
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Paula Madurga, MD, paumare@hotmail.com
Paula Madurga, MD
About this study
Official title: Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children.
The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated children with acute hypoxemic respiratory failure (AHRF), defined as PaO2/FiO2 ≤300 mmHg on PEEP≥5 cmH2O and FiO2≥0.3, admitted in a network of pediatric hospitals in Spain.
Read the detailed description
Prospective, multicenter, observational study focused on the prevalence and outcomes of Acute Hypoxemic Respiratory Failure in children. From a total of 40 pediatric ICUs in Spain, 22 PICUs agreed to participate.
All consecutive patients from 7 days to 16 years old admitted in the PICU will have been enrolled if they fulfilled the following criteria: 1) acute episode (within 7 days of a clinical insult), 2) on invasive mechanical ventilatory support, 3) PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), 4) Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.
This study is considered an audit, and informed consent is waived.
Period of study: 2 years (October 2019 to September 2021). Recruitment period: two consecutive months (i.e October-November followed by a period of no recruitment) until complete 12 months of recruitment (September 2021).
All investigators have received guidelines outlining the study design and the methods for data collection. All PICU admissions are screened daily for AHRF. Onset of AHRF was defined as the day on which the patient first met all inclusion criteria. All data are collected on standardized forms. Demographics, comorbidities, reason for initiation of IMV, arterial blood gases, laboratory, radiographic, hemodynamic and ventilator data were collected at study entry and during the first three days of AHRF diagnosis (T0 or time of inclusion in the study, 24 hours, days 2 and 3). Chest imaging (chest radiographs, lung ultrasound or computed tomography) were evaluated daily for the presence or absence of infiltrates, atelectasis, acute pulmonary edema, pleural effusion or pneumothorax. Tidal volume (VT) was calculated on the basis of the predicted body weight (PBW). Plateau pressure (Pplat) was determined after the application of a 0.5- to 1.0-sec end-inspiratory hold. Driving pressure was calculated as the difference between Pplat and PEEP. Patients meeting pediatric ARDS criteria were stratified into a mild, moderate, and severe according to PALICC definition and/or berlin definition. All patients are followed until PICU and hospital discharge.
Data are initially collected and stored at each center and then sent to study coordinators at the time of patient's hospital discharge.
Although patient care is not strictly protocolized, physicians are asked to follow the current standards of pediatric critical care management. For ventilatory management, it was recommended that all patients be ventilated with a VT of 6-8 mL/kg PBW, at a ventilatory rate to maintain PaCO2 at 35-50 mm Hg, a Pplat <30 cm H2O, and PEEP and FiO2 combinations to maintain PaO2 >60 mm Hg or SpO2 >90%.
Statistical Analysis: for the main objective of the study, a descriptive analysis including clinical variables, mechanical ventilation data, respiratory settings and ancillary measures will be performed.
- Conditions
- Acute Respiratory Insufficiency
- Being tested
- Mechanical ventilation
- Keywords
- respiratory failure, mechanical ventilation, children
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Ventilatory support
| Study group | Role | What they receive |
|---|---|---|
| Hypoxemic Respiratory Failure | Consecutive intubated patients receiving invasive mechanical ventilation with a PaO2/FiO2 ≤300 mmHg under a PEEP of 5 cmH2O or more and FiO2 of 0.3 or more. Receives: Device: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hypoxemic acute respiratory failure.
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.
Measured: 12 months
Secondary outcomes (1)
Death in the ICU and in the hospital
Outcome after discharge from ICU and before discharge to home (overall and in each category of acute hypoxemic respiratory failure).
Measured: through study completion, an average of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Oct 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yolanda Lopez Fernandez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Consorcio Centro de Investigación Biomédica en Red (CIBER), Hospital Universitario de Gran Canaria Doctor Negrín
- Responsible party
- Sponsor-investigator, Yolanda Lopez Fernandez, Hospital de Cruces
- Investigators
- Jesús Villar Hernández, MD, PhD, Study director, Multidisciplinary Organ Dysfunction Evaluation Research Network (MODERN). Research Unit, hospital universitario dr. negrín, Las Palmas de gran Canaria, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791501
- Sponsor's protocol ID
- PI201935
- Acronym
- PANDORA-child
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Fernandez Y, Azagra AM, de la Oliva P, Modesto V, Sanchez JI, Parrilla J, Arroyo MJ, Reyes SB, Pons-Odena M, Lopez-Herce J, Fernandez RL, Kacmarek RM, Villar J; Pediatric Acute Lung Injury Epidemiology and Natural History (PED-ALIEN) Network. Pediatric Acute Lung Injury Epidemiology and Natural History study: Incidence and outcome of the acute respiratory distress syndrome in children. Crit Care Med. 2012 Dec;40(12):3238-45. doi: 10.1097/CCM.0b013e318260caa3.
PubMed 22990455Villar J, Blanco J, Anon JM, Santos-Bouza A, Blanch L, Ambros A, Gandia F, Carriedo D, Mosteiro F, Basaldua S, Fernandez RL, Kacmarek RM; ALIEN Network. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14.
PubMed 21997128Kopczynska M, Sharif B, Pugh R, Otahal I, Havalda P, Groblewski W, Lynch C, George D, Sutherland J, Pandey M, Jones P, Murdoch M, Hatalyak A, Jones R, Kacmarek RM, Villar J, Szakmany T, On Behalf Of The Pandora-Wales Investigators. Prevalence and Outcomes of Acute Hypoxaemic Respiratory Failure in Wales: The PANDORA-WALES Study. J Clin Med. 2020 Oct 31;9(11):3521. doi: 10.3390/jcm9113521.
PubMed 33142837Lopez-Fernandez YM, Martinez-de-Azagra A, Reyes-Dominguez SB, Gomez-Zamora A, Herrera-Castillo L, Coca-Perez A, Parrilla-Parrilla J, Medina A, Garcia-Iniguez JP, Brezmes-Raposo M, Hernandez-Yuste A, Llorente de la Fuente AM, Ibarra de la Rosa I, Leon-Gonzalez JS, Trastoy-Quintela J, Arjona-Villanueva D, Gonzalez-Martin JM, Szakmany T, Villar J; Prevalence AND Outcome of acute hypoxemic Respiratory fAilure in children (PANDORA-CHILD) Network. The Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA) Study in Mechanically Ventilated Children: Prospective Multicenter Epidemiology in Spain, 2019-2021. Pediatr Crit Care Med. 2025 Jun 1;26(6):e759-e772. doi: 10.1097/PCC.0000000000003743. Epub 2025 Apr 25.
PubMed 40277417
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children.
- ClinicalTrials.gov ID
- NCT04791501
- Acronym / sponsor ID
- PANDORA-child / PI201935
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- respiratory failure, mechanical ventilation, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yolanda Lopez FernandezUniversity, hospital or other
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Consorcio Centro de Investigación Biomédica en Red (CIBER), Hospital Universitario de Gran Canaria Doctor Negrín
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is aimed to establish the epidemiological characteristics and clinical outcomes of mechanically ventilated children with acute hypoxemic respiratory failure (AHRF), defined as PaO2/FiO2 ≤300 mmHg on PEEP≥5 cmH2O and FiO2≥0.3, admitted in a network of pediatric hospitals in Spain.
Detailed description
Prospective, multicenter, observational study focused on the prevalence and outcomes of Acute Hypoxemic Respiratory Failure in children. From a total of 40 pediatric ICUs in Spain, 22 PICUs agreed to participate.
All consecutive patients from 7 days to 16 years old admitted in the PICU will have been enrolled if they fulfilled the following criteria: 1) acute episode (within 7 days of a clinical insult), 2) on invasive mechanical ventilatory support, 3) PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), 4) Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.
This study is considered an audit, and informed consent is waived.
Period of study: 2 years (October 2019 to September 2021). Recruitment period: two consecutive months (i.e October-November followed by a period of no recruitment) until complete 12 months of recruitment (September 2021).
All investigators have received guidelines outlining the study design and the methods for data collection. All PICU admissions are screened daily for AHRF. Onset of AHRF was defined as the day on which the patient first met all inclusion criteria. All data are collected on standardized forms. Demographics, comorbidities, reason for initiation of IMV, arterial blood gases, laboratory, radiographic, hemodynamic and ventilator data were collected at study entry and during the first three days of AHRF diagnosis (T0 or time of inclusion in the study, 24 hours, days 2 and 3). Chest imaging (chest radiographs, lung ultrasound or computed tomography) were evaluated daily for the presence or absence of infiltrates, atelectasis, acute pulmonary edema, pleural effusion or pneumothorax. Tidal volume (VT) was calculated on the basis of the predicted body weight (PBW). Plateau pressure (Pplat) was determined after the application of a 0.5- to 1.0-sec end-inspiratory hold. Driving pressure was calculated as the difference between Pplat and PEEP. Patients meeting pediatric ARDS criteria were stratified into a mild, moderate, and severe according to PALICC definition and/or berlin definition. All patients are followed until PICU and hospital discharge.
Data are initially collected and stored at each center and then sent to study coordinators at the time of patient's hospital discharge.
Although patient care is not strictly protocolized, physicians are asked to follow the current standards of pediatric critical care management. For ventilatory management, it was recommended that all patients be ventilated with a VT of 6-8 mL/kg PBW, at a ventilatory rate to maintain PaCO2 at 35-50 mm Hg, a Pplat <30 cm H2O, and PEEP and FiO2 combinations to maintain PaO2 >60 mm Hg or SpO2 >90%.
Statistical Analysis: for the main objective of the study, a descriptive analysis including clinical variables, mechanical ventilation data, respiratory settings and ancillary measures will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoxemic Respiratory Failure | – | Device: Mechanical ventilationConsecutive intubated patients receiving invasive mechanical ventilation with a PaO2/FiO2 ≤300 mmHg under a PEEP of 5 cmH2O or more and FiO2 of 0.3 or more. |
Who may qualify
- Ages
- 7 days to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All consecutive patients from 7 days to 16 years old admitted in the PICU with an acute episode (within 7 days of a clinical insult) of hipoxemia defined as PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264), and on invasive mechaniccal ventilatio with a PEEP ≥ 5 cmH2O and FiO2 ≥ 0.3.
Key inclusion criteria (5 listed)
- Patients from 7 days to 16 years old admitted in the PICU.
- Acute episode (within 7 days of a clinical insult)
- On invasive mechanical ventilatory support
- PaO2/FiO2 ≤ 300 mmHg (or SpO2/FiO2 ≤ 264)
- Positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FiO2 ≥ 0.3.
Key exclusion criteria (1 listed)
- Non-invasive respiratory support *Aged >16 years or < 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationVentilatory support | Device | Hypoxemic Respiratory Failure |
Primary outcome
Prevalence of hypoxemic acute respiratory failure.
Time frame: 12 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.
1 secondary outcome
Death in the ICU and in the hospital
Time frame: through study completion, an average of 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 22990455Lopez-Fernandez Y, Azagra AM, de la Oliva P, Modesto V, Sanchez JI, Parrilla J, Arroyo MJ, Reyes SB, Pons-Odena M, Lopez-Herce J, Fernandez RL, Kacmarek RM, Villar J; Pediatric Acute Lung Injury Epidemiology and Natural History (PED-ALIEN) Network. Pediatric Acute Lung Injury Epidemiology and Natural History study: Incidence and outcome of the acute respiratory distress syndrome in children. Crit Care Med. 2012 Dec;40(12):3238-45. doi: 10.1097/CCM.0b013e318260caa3.
- Background: PubMed 21997128Villar J, Blanco J, Anon JM, Santos-Bouza A, Blanch L, Ambros A, Gandia F, Carriedo D, Mosteiro F, Basaldua S, Fernandez RL, Kacmarek RM; ALIEN Network. The ALIEN study: incidence and outcome of acute respiratory distress syndrome in the era of lung protective ventilation. Intensive Care Med. 2011 Dec;37(12):1932-41. doi: 10.1007/s00134-011-2380-4. Epub 2011 Oct 14.
- Background: PubMed 33142837Kopczynska M, Sharif B, Pugh R, Otahal I, Havalda P, Groblewski W, Lynch C, George D, Sutherland J, Pandey M, Jones P, Murdoch M, Hatalyak A, Jones R, Kacmarek RM, Villar J, Szakmany T, On Behalf Of The Pandora-Wales Investigators. Prevalence and Outcomes of Acute Hypoxaemic Respiratory Failure in Wales: The PANDORA-WALES Study. J Clin Med. 2020 Oct 31;9(11):3521. doi: 10.3390/jcm9113521.
- Derived from this study: PubMed 40277417Lopez-Fernandez YM, Martinez-de-Azagra A, Reyes-Dominguez SB, Gomez-Zamora A, Herrera-Castillo L, Coca-Perez A, Parrilla-Parrilla J, Medina A, Garcia-Iniguez JP, Brezmes-Raposo M, Hernandez-Yuste A, Llorente de la Fuente AM, Ibarra de la Rosa I, Leon-Gonzalez JS, Trastoy-Quintela J, Arjona-Villanueva D, Gonzalez-Martin JM, Szakmany T, Villar J; Prevalence AND Outcome of acute hypoxemic Respiratory fAilure in children (PANDORA-CHILD) Network. The Prevalence and Outcome of Acute Hypoxemic Respiratory Failure (PANDORA) Study in Mechanically Ventilated Children: Prospective Multicenter Epidemiology in Spain, 2019-2021. Pediatr Crit Care Med. 2025 Jun 1;26(6):e759-e772. doi: 10.1097/PCC.0000000000003743. Epub 2025 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda M López-Fernández, MD contact
Jesús Villar Hernández, MD, PhD study director
Multidisciplinary Organ Dysfunction Evaluation Research Network (MODERN). Research Unit, hospital universitario dr. negrín, Las Palmas de gran Canaria, Spain.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Insufficiency, run by Yolanda Lopez Fernandez at 23 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yolanda M López-Fernández, MD (0034946006000 ext. 6582, yolandamarg.lopezfernandez@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypoxemic acute respiratory failure. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791501, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.