- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00221819
Gases Humidification During Noninvasive Ventilation : Heat and Moisture Exchanger or Heated Humidifier ?
Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Objective: Few data are reported in the field of noninvasive ventilation (NIV) regarding humidification devices. It was previously suggested that standard heat and moisture exchangers (HME) had adverse gasometrical and clinical outcomes in acute respiratory failure (ARF) of chronic respiratory failure patients (CRF). This study was performed to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to heated humidifier (HH).
Design: Prospective randomized cross-over study. Setting: A 16-bed medical intensive care unit (ICU) and a 14-bed medico surgical ICU.
Patients: Patients receiving NIV for ARF in the context of CRF or hypoxic ARF and patients with persistent weaning failure receiving NIV just after extubation.
Measurements: HME and HH were randomly compared during 2 NIV periods of 30 minutes separated by a 20 to 30 minutes period of spontaneous breathing with oxygen. ABG were collected at baseline and at the end of each period. As well as respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation. Two sets of patients were successively studied whether they have a flex tube added to the ventilatory circuit or not.
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bordeaux, Frankrig, 33076
- Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients receiving NIV for ARF in the context of CRF, hypoxic ARF or patients with persistent weaning failure receiving NIV just after extubation
Exclusion Criteria:
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Air blood gases at the end of each study period (one with HME, one with HH)
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Sekundære resultatmål
Resultatmål |
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Respiratory parameters including volumes, pressures, P0.1, a comfort score, capnometry and oxygen saturation at the end of each study period (one with HME, one with HH)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: alexandre Boyer, Dr, University Hospital, Bordeaux
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9300-02
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