Acute Respiratory InsufficiencyPANDORAWALESNCT03358043
Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales
An observational study of Acute Respiratory Insufficiency, run by Hospital Universitario de Gran Canaria Doctor Negrín at 12 sites in United Kingdom.
Trial summary
This study is aimed to establish the epidemiological chacacteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a network of hospitals from Wales (U.K.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Insufficiency
- What is being tested?
- mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 1,100 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 1 Oct 2017to 31 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients admitted to participating ICUs will be screened daily. Only patients meeting inclusion criteria for acute hypoxemic respiratory failure will be enrolled into the study.
Who may be able to join
- 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.
Who cannot join
- No patients shhould be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Nevill Hall Hospital
Abergavenny
Ysbyty Gwynedd
Bangor
Cardiff University
Cardiff
University Hospital of Wales
Cardiff
Glangwili General Hospital
Carmarthen
Withybush General Hospital
Haverfordwest
Royal Glamorgan Hospital
Llantrisant
Prince Charles Hospital
Merthyr Tydfil
Royal Gwent Hospital
Newport
Ysbyty Glan Clwyd
Rhyl
Morriston Hospital
Swansea
Wrexham Maelor Hospital
Wrexham
About this study
This study is aimed to establish the epidemiological chacacteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a network of hospitals from Wales (U.K.).
Read the 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 hospitals from Wales (U.K.). 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. This study will be done simultaneously with the PANDORA (NCT03145974) in Spain.
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 for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.
- Conditions
- Acute Respiratory Insufficiency
- Being tested
- mechanical ventilation
- Keywords
- respiratory failure, mechanical ventilation, prevalence
- 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
Also called ventilatory support
Consecutive intubated pateints receiving mechanical ventilation with a PaO2/FiO2≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more.
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; (ii) total number of mechanically ventilated patients during the study period; and (iii) per ICU bed available over the study period.
Measured: 4 months
Secondary outcomes (1)
Death in the hospital
outcome before discharge to home (overall and in each category of acute hypoxemic respiratory failure)
Measured: Hospital stay (maximum 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start1 Oct 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Científica Pulmón y Ventilación Mecánica, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Responsible party
- Principal investigator, Jesus Villar, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Jesús Villar, MD, Study chair, Clinical ScientistRobert M Kacmarek, PhD, Study chair, Clinical Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358043
- Sponsor's protocol ID
- ACPVM170916
- Acronym
- PANDORAWALES
- Status last verified
- Jul 2019
- First submitted
- 24 Nov 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data from all patients must be collected and pooled by the coordinating center (Dr. Tamas Szakmany, All Wales Critical Care and Trauma Network)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Wales
- ClinicalTrials.gov ID
- NCT03358043
- Acronym / sponsor ID
- PANDORAWALES / ACPVM170916
- Conditions
- Acute Respiratory Insufficiency
- Keywords
- respiratory failure, mechanical ventilation, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Collaborators
- Asociación Científica Pulmón y Ventilación Mecánica, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 30 Nov 2017 (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.
This study is aimed to establish the epidemiological chacacteristics and clinical outcomes of mechanically ventilated patients with acute hypoxemic respiratory failure admitted in a network of hospitals from Wales (U.K.).
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 hospitals from Wales (U.K.). 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. This study will be done simultaneously with the PANDORA (NCT03145974) in Spain.
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 for stratification of lung severity, and to examine the prognosis of hypoxemic respiratory failure, and risk factors associated with fatal outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients admitted to participating ICUs will be screened daily. Only patients meeting inclusion criteria for acute hypoxemic respiratory failure will be enrolled into the study.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- No patients shhould be excluded (if they meet all the inclusion criteria), regardless of the underlying disease, estimated life expectancy, or duration of invasive mechanical ventilation.
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 ventilationAlso: ventilatory supportConsecutive intubated pateints receiving mechanical ventilation with a PaO2/FiO2≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more. | Device | – |
Primary outcome
Prevalence of hypoxemic acute respiratory failure
Time frame: 4 months
The investigators will calculate the prevalence in relation to: (i) total number of ICU admissions; (ii) total number of mechanically ventilated patients during the study period; and (iii) per ICU bed available over the study period.
1 secondary outcome
Death in the hospital
Time frame: Hospital stay (maximum 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided. Data from all patients must be collected and pooled by the coordinating center (Dr. Tamas Szakmany, All Wales Critical Care and Trauma Network)
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Influence of Patient Positioning During Nasal Lavage
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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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.
Jesús Villar, MD study chair
Clinical Scientist
Robert M Kacmarek, PhD study chair
Clinical Scientist
12 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 Hospital Universitario de Gran Canaria Doctor Negrín at 12 sites in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypoxemic acute respiratory failure (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.