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Weaning From Nasal High Flow Therapy
26 januari 2022 bijgewerkt door: Prof Jean-Damien RICARD, Hôpital Louis Mourier
Weaning From Nasal High Flow Therapy: an Explorative Study Assessing the Usefulness of the ROX Index to Predict Outcome of the Weaning Process in Combination With a Withdrawal Trial
Nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure.
It has been shown to improve patient comfort, increase oxygenation and reduce need for intubation in some patients.
The Respiratory Oxygenation (ROX) index has been established as a simple tool to help clinicians identify those patients who will succeed and those who will fail under nasal high flow and therefore predict the need for intubation.
However, when nasal high flow therapy is successful, little is known as to how and when weaning of this device should be performed and what are the predictors of a safe withdrawal of the device.
The objectives of this retrospective exploratory study are to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial; to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
Although nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure, and its benefits have been shown in multiple studies, little is known as to how and when weaning from the technique device should be performed and what are the predictors of a safe withdrawal.
The Respiratory Oxygenation (ROX) index was established and tested to predict outcome of nasal high flow therapy in patients with acute hypoxemic respiratory failure.
It combines three parameters available at the bedside that reflect patient's respiratory status: respiratory rate, the level of the inspired fraction of oxygen (FiO2) and pulse oximetry (SpO2).
Importantly, the combination of these three parameters outweighed the performance of each parameter taken separately to predict nasal high flow therapy outcome.
Since its initial publication, several studies coming from different countries have confirmed the potential for the ROX index to predict need for intubation in patients with acute hypoxemic respiratory failure, thus making a valuable tool accessible to everyone, including nurses, to monitor on a routine basis.
Because it reflects the patient's respiratory status, the greater the score, the better the patient's condition.
Hence, one may hypothesize that, at the other end of the spectrum of respiratory failure (i.e., at the stage of weaning and withdrawal of the high flow device when the patient has considerably improved), the ROX index may also help identify those patients who will be successfully separated from the nasal high flow support.
To date, one study has suggested that among several parameters, the value of the ROX index could be associated with successful cessation of nasal high flow.
Here, in a retrospective exploratory study, investigators aim to to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial (average duration of use of nasal high flow before weaning, number of weaning trials, number of failed and successful weaning trials.); to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy; A successful withdrawal is defined as the withdrawal of nasal high flow without necessity of placing the patient back on nasal high flow within the following 24h.
A failed withdrawal is defined by the need to resume nasal high flow within the 24h hours following the withdrawal.
The possible identification of a cut-off value may help clinicians initiate earlier weaning from nasal high flow.
Studietype
Observationeel
Inschrijving (Werkelijk)
62
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Colombes, Frankrijk, 92700
- Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
ICU patients treated with nasal high flow therapy
Beschrijving
Inclusion Criteria:
- ICU patient treated with nasal high flow
Exclusion Criteria:
- age < 18 years
- concomitant treatment with non-invasive ventilation
- acute hypercapnic respiratory failure
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal
Tijdsspanne: through each nasal high flow therapy, that lasts an average of 24hours
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the ROX index the closest to the time at which nasal high flow is withdrawn will be recorded
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through each nasal high flow therapy, that lasts an average of 24hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
use of nasal high flow before weaning
Tijdsspanne: through each nasal high flow therapy, that lasts an average of 24 hours
|
average duration of nasal high flow therapy before initiating a withdrawal trial (in hours)
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through each nasal high flow therapy, that lasts an average of 24 hours
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number of withdrawal trials
Tijdsspanne: through each nasal high flow therapy, that lasts an average of 24 hours
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the number of trials each patient will have performed will be recorded
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through each nasal high flow therapy, that lasts an average of 24 hours
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number of patients who failed a withdrawal trial
Tijdsspanne: throughout study duration which is a one-year period
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withdrawal failure is defined by patients who required to be placed back on nasal high flow after withdrawal of the high flow device within 24 hours of withdrawal.
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throughout study duration which is a one-year period
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number of patients who succeeded a withdrawal trial
Tijdsspanne: throughout study duration which is a one-year period
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withdrawal success is defined by patients that have not required to be placed back on nasal high flow after withdrawal of the high flow device within 24 hours of withdrawal.
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throughout study duration which is a one-year period
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
- Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
- Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2019
Primaire voltooiing (Werkelijk)
31 december 2019
Studie voltooiing (Werkelijk)
31 augustus 2021
Studieregistratiedata
Eerst ingediend
11 januari 2022
Eerst ingediend dat voldeed aan de QC-criteria
26 januari 2022
Eerst geplaatst (Werkelijk)
27 januari 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 januari 2022
Laatste update ingediend die voldeed aan QC-criteria
26 januari 2022
Laatst geverifieerd
1 januari 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HLM_JDR11
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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