Noninvasive Ventilation Versus High-Flow Nasal Cannula After Extubation in High-Risk ICU Patients (NIV-HFNC)
Comparative Study Between Noninvasive Ventilation and High Flow Nasal Cannula in Patients With High Risk of Extubation Failure
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egypten, 13511
- Benha University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
inclusion criteria
- Age ≥18 years.
- Received invasive mechanical ventilation for at least 24 hours.
- Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
- High risk of extubation failure, defined by the presence of at least four of the following risk factors:
Age >65 years. APACHE II score >12 on the day of extubation. Body mass index >30 kg/m². Inadequate secretion management. Difficult or prolonged weaning. Two or more comorbidities. Acute heart failure requiring mechanical ventilation. Moderate-to-severe chronic obstructive pulmonary disease. Airway patency problems. Prolonged mechanical ventilation. Hypercapnia at the end of the spontaneous breathing trial.
Exclusion Criteria:
- Age <18 years.
- Presence of a tracheostomy.
- Accidental extubation.
- Self-extubation.
- Contraindication to noninvasive ventilation.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: NIV
Patients received noninvasive ventilation immediately after planned extubation according to the study protocol.
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NIV was initiated immediately after extubation using bilevel positive airway pressure delivered via a properly fitted face mask with active humidification using a Dräger Savina 300 ventilator (Drägerwerk AG & Co. KGaA, Lübeck, Germany).
Ventilator settings were adjusted to achieve a respiratory rate <26 breaths/min, tidal volume of 6-8 mL/kg predicted body weight, and adequate oxygenation (SpO₂ ≥92%, pH ≥7.35).
Sedation was not permitted.
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Aktiv komparator: HFNC
Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol.
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HFNC was applied immediately after extubation using a heated humidified high-flow nasal cannula system (BioVent A-Series, Model: BioHF BB60101; BIO-AOI, Cairo, Egypt). Flow was initially set at 10 L/min and titrated up to 60 L/min according to patient tolerance. Gas temperature was maintained at 37°C. In both groups, FiO₂ was adjusted to maintain SpO₂ ≥92%. After 48 hours, respiratory support was discontinued and conventional oxygen therapy was provided if required. Rescue NIV was not allowed in the HFNC group. All patients received standardized care. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Reintubation Rate
Tidsramme: 7 days
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Proportion of patients requiring reintubation following planned extubation.
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7 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Reintubation
Tidsramme: 7 days
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Time elapsed from extubation to reintubation among patients requiring reintubation.
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7 days
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RC.16.7.2025
Plan for individuelle deltagerdata (IPD)
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