Randomisert klinisk studie for prediktorer for vellykket ekstubasjon av pediatriske pasienter fra mekanisk ventilasjon enten på høyhastighets nasal insufflasjon eller enkel nasal oksygen og sammenligning av utfallet
Prediktorer for vellykket ekstubasjon av pediatriske pasienter fra mekanisk ventilasjon med eller uten post-ekstubasjons høyhastighets neseinsuflasjon
A randomized clinical trial about predictors of successful extubation of pediatric patients from mechanical ventilation either on High Velocity Nasal Insufflation or simple nasal oxygen and comparing the outcome
Studieoversikt
Status
Detaljert beskrivelse
A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Sherin T. Fayez Ali, PICU doctor
- Telefonnummer: +01153576707
- E-post: tareksherin16@gmail.com
Studiesteder
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt
- Rekruttering
- Cairo University
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Ta kontakt med:
- Cairo University Cairo University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age between 2 months and 13 years old with minimum weight 4kg
- Both sexes
- Patients on mechanical ventilation for at least 24 hours for any indication
Exclusion Criteria:
- Patients not ready for weaning from mechanical ventilation
- Contraindications to use of High velocity nasal insufflation
- Prolonged mechanical ventilation for more than 21 days
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Eks tubasjon av pediatriske pasienter med høyhastighets nasal insufflasjon
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A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality. A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality. |
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Aktiv komparator: Ekstubasjon av pediatriske pasienter på enkel oksygen
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A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality. A randomized clinical study is comparing between extubation on High Velocity Nasal Insufflation or simple nasal Oxygen ensuring that all patients had successful weaning predictors before extubation and comparing the outcome whether patient needed upgrading of oxygen support or re-intubation within 48 hours, presence of respiratory distress or stridor post extubation, time of complete weaning of oxygen support to room air and also morbidity and mortality. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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comparing the need for reintubation within 48 hours afterr extubation using High Velocity Nasal Insufflation versus simple oxygen
Tidsramme: 48 hours
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Successful extubation with no need for reintubation within 48 hours among pediatric ICU patients in those using High Velocity Nasal Insufflation versus simple oxygen |
48 hours
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Cairo University Cairo University, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MD-299-2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
No individual participant data will be shared as per the individual signed consent to participate.
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