Prevalence AND Outcome of Acute Hypoxemic Respiratory fAilure in CHILDren (PANDORA-CHILD)

Acute Respiratory Insufficiency Clinical Trial

— PANDORA-child  

Official title:

Prevalence and Outcome of Acute Hypoxemic Respiratory Failure in Children.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791501
• Other study ID #: PI201935
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2021
• Source: Hospital de Cruces
• Contact: Yolanda M López-Fernández, MD
• Phone: 0034946006000
• Email: yolandamarg.lopezfernandez[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Insufficiency
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Mechanical ventilation
Ventilatory support

Locations

Country	Name	City	State
Spain	Cruces University Hospital	Barakaldo	Bizkaia
Spain	Hospital Universitario	Burgos
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	Complejo Hospitalario Donosti	Donostia	Gipuzkoa
Spain	Hospital Universitario	Las Palmas De Gran Canaria
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen de la Arrixaca	Madrid
Spain	Niño Jesús University Hospital	Madrid
Spain	Hospital Universitario	Málaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Universitario Virgen del Camino	Pamplona
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Santiago de Compostela	Santiago De Compostela
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Tenerife	Tenerife
Spain	Hospital Universitario Virgen de la Salud	Toledo
Spain	Hospital Universitario La fe	Valencia
Spain	Hospital Clinico Universitario	Valladolid
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (4)

Lead Sponsor	Collaborator
Yolanda Lopez Fernandez	Consorcio Centro de Investigación Biomédica en Red, M.P., Dr. Negrin University Hospital, Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Kopczynska 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). pii: E3521. doi: 10.3390/jcm9113521. — View Citation

López-Fernández Y, Azagra AM, de la Oliva P, Modesto V, Sánchez JI, Parrilla J, Arroyo MJ, Reyes SB, Pons-Ódena M, López-Herce J, Fernández 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. — View Citation

Villar J, Blanco J, Añón JM, Santos-Bouza A, Blanch L, Ambrós A, Gandía F, Carriedo D, Mosteiro F, Basaldúa S, Fernández 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. Erratum in: Intensive Care Med. 2011 Dec;37(12):1942. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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).	through study completion, an average of 60 days