- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03020394
Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation
13. januar 2020 opdateret af: Qingyuan Zhan, China-Japan Friendship Hospital
Comparison of High Flow Nasal Cannula, Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)
Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of COPD.
Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates.
But there's no high-quality clinical studies which can confirm this.
Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in order to reduce IMV-related complications and improve patients' outcomes.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
In part of the patients who were AECOPD with pH <7.25 , preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of VAP.
Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates.
At present, there's no high-quality clinical studies which can confirm this, and clinical guidelines do not have a recommendation on the use of NPPV in these patients.
Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, as well as the progress of medical technology in NPPV in recent years, in order to reduce IMV-related complications and improve patients' outcomes.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
208
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Beijing
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Beijing, Beijing, Kina, 100028
- Rekruttering
- China-Japan Friendship Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
All patients with acute exacerbation of chronic obstructive pulmonary disease in medical ICU.
Beskrivelse
Inclusion Criteria:
- AECOPD;
Exclusion Criteria:
- refuse to engage in the study;
- have been included in other study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Noninvasive ventilation
Noninvasive positive pressure ventilation is achieved by Philips Respironics V60/Vision ventilator.
Choose bilevel positive airway pressure mode, and adjust the fraction of inspire oxygen(FiO2) or oxygen flow rate to maintain patient's oxygen saturation(SpO2) between 88% to 92%.
Parameter adjustment and weaning of NPPV follow the protocols used before.
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Invasive ventilation
Intubated immediately and connected to the ventilator.
Parameter adjustment and weaning of IPPV follow the protocols used before.
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High flow nasal cannula
High flow nasal cannula of different models (large, medium and small) are selected depending on the size and comfort of the patient's nostrils.
Adjusting the oxygen flow rate (O2 Flow) maintains the patient's SpO2 88% to 92%.
The flow was initially adjusted to 25 L/min and the flow was gradually adjusted to the patient's maximum tolerance.
The inspiratory gas temperature (31 to 37 °C) was set to the patient's maximum tolerance level.
If the patient's condition deteriorates and the tracheal intubation standard is met , the patient is recommended to undergo invasive ventilation treatment, but the choice of the final respiratory support method should be decided by the attending physician, patient and family.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The incidence of ventilator-associated pneumonia (VAP)
Tidsramme: 90days
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90days
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The all cause mortality of ICU and hospitalization
Tidsramme: 90 days
|
90 days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
The length of stay of ICU and hospitalization
Tidsramme: 90 days
|
90 days
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The length of stay of mechanical ventilation
Tidsramme: 90 days
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90 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2017
Primær færdiggørelse (Forventet)
1. december 2020
Studieafslutning (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
9. januar 2017
Først indsendt, der opfyldte QC-kriterier
11. januar 2017
Først opslået (Skøn)
13. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016YFC1304304-3
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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