HFNC Versus NIV in Hypercapneic COPD Patients
Gas Exchange, Clinical Outcomes, and Tolerability of High-Flow Nasal Cannula Versus Non-Invasive Ventilation in COPD Patients With Mild-to-Moderate Hypercapnic Respiratory Failure
Aim: To compare gas exchange trends, clinical outcomes, and tolerability between HFNC and NIV in COPD patients with mild-to-moderate hypercapnic respiratory failure.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mohammed Shehta, associate professor-chest med.
- Telefonnummer: 01004344106
- E-mail: dr_mshehta@mans.edu.eg
Studiesteder
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-
Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypten, 35516
- Rekruttering
- Faculty of Medicine, Mansoura University
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Kontakt:
- Mohammed Shehta
- E-mail: dr_mshehta@mans.edu.eg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- COPD patients hospitalized with mild-to-moderate hypercapnic respiratory failure, defined as arterial pH [range, e.g., 7.25-7.35] and PaCO2 [threshold, e.g., >45 mmHg and less 60 mmHg].
Exclusion Criteria:
- patients with altered mental state, confused, severe agitation or not cooperative were excluded. Also, severe acidosis (pH <7.25), hemodynamic instability, facial trauma or surgery, cases with severe nasal deformity, immediate indication for invasive ventilation, patient refusal, cases with respiratory rate more than 35 breaths per minute. Respiratory exhaustion, excess use of respiratory accessory muscles, Patients with breathing disorders during sleep as well as cases of upper airway obstruction and patients with history of chronic home ventilation prior admission were another items for exclusion
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 |
|---|---|
|
Eksperimentel: Arm 1: high flow nasal canula
patients recieve high flow nasal canula oxygen therapy according to study protocol |
high flow nasal canula oxygen therapy according to study protocol |
|
Aktiv komparator: Arm 2: non invasive ventilation (NIV)
patients recieve NIV according to study protocol |
non invasive ventilation according to study protocol |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
treatment failure
Tidsramme: From initiation of the assigned respiratory support until hospital discharge, assessed throughout the hospitalization (up to 30 days).
|
treatment failure defined as the need for escalation from assigned respiratory support to a higher level of ventilatory support during hospitalization. In HFNC group, treatment failure is defined as the need for rescue NIV or invasive mechanical ventilation. In the NIV group ,treatment failure is defined as the need of invasive mechanical ventilation. ( number and percentages of patients experiencing treatment failure in each treatment group) |
From initiation of the assigned respiratory support until hospital discharge, assessed throughout the hospitalization (up to 30 days).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
serial arterial blood gas parameters at 12, 24 and 48 hours
Tidsramme: at 12, 24, 48 hours after start of respiratory support
|
serial arterial blood gas parameters (pH, PaCO2, HCO3) at 12, 24 and 48 hours; |
at 12, 24, 48 hours after start of respiratory support
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MFM-IRB R.25.09.3356
Plan for individuelle deltagerdata (IPD)
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