Prevalence AND Outcome of Acute Hypoxemic Respiratory fAilure in CHILDren (PANDORA-CHILD) (PANDORA-child)
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| ClinicalTrials.gov Identifier: NCT04791501 |
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Recruitment Status :
Recruiting
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Acute Respiratory Insufficiency | Device: Mechanical ventilation |
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 Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children. |
| Actual Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | October 30, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Device: Mechanical ventilation
Ventilatory support |
- 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.
- Death in the ICU and in the hospital [ Time Frame: through study completion, an average of 60 days ]Outcome after discharge from ICU and before discharge to home (overall and in each category of acute hypoxemic respiratory failure).
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| Ages Eligible for Study: | up to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Non-invasive respiratory support *Aged >16 years or < 7 days.
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): NCT04791501
| Contact: Yolanda M López-Fernández, MD | 0034946006000 ext 6582 | yolandamarg.lopezfernandez@osakidetza.eus | |
| Contact: Amelia Martinez de Azagra, MD | 0034630122450 | ameliamartinezdeazgra@gmail.com |
Show 23 study locations
| Study Director: | Jesús Villar Hernández, MD, PhD | Multidisciplinary Organ Dysfunction Evaluation Research Network (MODERN). Research Unit, hospital universitario dr. negrín, Las Palmas de gran Canaria, Spain. |
| Responsible Party: | Yolanda Lopez Fernandez, Principal Investigator, Hospital de Cruces |
| ClinicalTrials.gov Identifier: | NCT04791501 |
| Other Study ID Numbers: |
PI201935 |
| First Posted: | March 10, 2021 Key Record Dates |
| Last Update Posted: | March 10, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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respiratory failure mechanical ventilation children |
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Respiratory Insufficiency Pulmonary Valve Insufficiency Respiration Disorders Respiratory Tract Diseases |
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |