Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
260
Countries
1
Sites
8
Weaning of Mechanical ventilation
The primary objective will be the reduction of extubation failure.
Key facts
- Sponsor
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 23 Apr 2025 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fundacion FISABIO · Hospital Universitario Doctor Peset
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective will be the reduction of extubation failure.
Secondary objectives 10
- Reduction of reintubation
- Reduction of nosocomial infections
- Reduction of tracheotomy
- Reduction of organ failure
- Reduction of ICU stay
- Reduction of hospital stay
- Reduction of mortality in ICU
- Reduction of mortality at 28 days
- Reduction of mortality at hospital discharge
- Reduction of duration of mechanical ventilation
Conditions and MedDRA coding
Weaning of Mechanical ventilation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10066829 | Weaning failure | 100000004863 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- Age ≥ 65 years
- Body mass index (BMI)>30
- Chronic obstructive pulmonary disease (COPD) or asthma as a cause of invasive mechanical ventilation
- Cardiac failure as a cause of intubation or history of ejection fraction <= 30%
- Acute Physiology and Chronic Health Evaluation (APACHE II) > 12 at the time of extubation
- Time of mechanical ventilation > 7 days
- Positive water balance
- Difficult or prolonged weaning
- Pneumonia (or any medical pathology over surgical) as a cause of ARF
- Hypercapnia (paCO2 > 45 mmHg) at the time of extubation
- Ineffective cough
- Abundant secretions
Exclusion criteria 11
- Structural neurologic disease
- Not intubation order
- Life support therapy limitation
- Tracheotomized
- Spinal cord injury
- Scheduled surgical intervention in the next 48 hours post-extubation
- Re-admission
- Transfer to another center
- Refusal of the patient or relatives
- Direct extubation without performing a spontaneous breathing trial
- Contraindication to apply NIV or high flow oxygen
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Acute respiratory failure within 48 hours after extubation
Secondary endpoints 10
- Intubation
- Nosocomial infection
- Tracheotomy
- Organ failure
- ICU Mortality
- Hospital mortality
- 28-day mortality
- ICU length of stay
- Hospital length of stay
- Duration of mechanical ventilation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Oxígeno Medicinal Líquido Air Liquide 99,5% v/v, gas criogénico medicinal en recipientes fijos.
PRD349515 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, CRYOGENIC
- Route of administration
- INHALATION GAS
- Max daily dose
- 100 % percent
- Max total dose
- 100 % percent
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- 66974
- MA holder
- AIR LIQUIDE SANTE INTERNATIONAL
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Sponsor organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Address
- Avenida Cataluna 21
- City
- Valencia
- Postcode
- 46020
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Alberto Belenguer Muncharaz / Héctor Hernández Garcés
Public contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Alberto Belenguer Muncharaz / Héctor Hernández Garcés
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 260 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital De Sagunto
Intensive Care Unit, Calle De Ramon Y Cajal 46, 46520, Sagunto
Hospital General Universitario De Castellon
Intensive Care Unit, Avenida De Benicasim S/n, 12004, Castello De La Plana
Hospital Arnau De Vilanova De Valencia
Intensive Care Unit, Calle De San Clemente 12, 46015, Valencia
Hospital Francesc De Borja De Gandía
Intensive Care Unit, Avinguda De La Medicina 6, 46730, Gandia
Consorcio Hospitalario Provincial De Castellon
Intensive Care Unit, Avinguda Del Doctor Clara 19, 12006, Castello De La Plana
Hospital Universitario Dr Peset Aleixandre
Intensive Care Unit, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital De Manises
Intensive Care Unit, Avinguda De La Generalitat Valenciana 50, 46940, Manises
Hospital De Tortosa Verge De La Cinta
Intensive Care Unit, Calle De Les Esplanetes 44, 43500, Tortosa
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-04-23 | 2025-04-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo_2024-514640-81 | 2 |
| Recruitment arrangements (for publication) | K1_PROCEDIMIENTOS DE RECLUTAMIENTO_2024-514640-81-00 | 1 |
| Recruitment arrangements (for publication) | K1_PROCEDIMIENTOS DE RECLUTAMIENTO_2024-514640-81-00_For Public | 1 |
| Subject information and informed consent form (for publication) | L1_HIP_General_v1 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Oxigen | 1 |
| Synopsis of the protocol (for publication) | D1_Sinopsis protocolo_ESP_2024-514640-81 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Spain | Acceptable 2024-10-07
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-25 | Spain | Acceptable | 2025-01-14 |