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- Klinische Studie NCT05210881
Weaning From Nasal High Flow Therapy
26. Januar 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
62
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
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Colombes, Frankreich, 92700
- Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
ICU patients treated with nasal high flow therapy
Beschreibung
Inclusion Criteria:
- ICU patient treated with nasal high flow
Exclusion Criteria:
- age < 18 years
- concomitant treatment with non-invasive ventilation
- acute hypercapnic respiratory failure
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal
Zeitfenster: through each nasal high flow therapy, that lasts an average of 24hours
|
the ROX index the closest to the time at which nasal high flow is withdrawn will be recorded
|
through each nasal high flow therapy, that lasts an average of 24hours
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
use of nasal high flow before weaning
Zeitfenster: 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)
|
through each nasal high flow therapy, that lasts an average of 24 hours
|
|
number of withdrawal trials
Zeitfenster: through each nasal high flow therapy, that lasts an average of 24 hours
|
the number of trials each patient will have performed will be recorded
|
through each nasal high flow therapy, that lasts an average of 24 hours
|
|
number of patients who failed a withdrawal trial
Zeitfenster: throughout study duration which is a one-year period
|
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.
|
throughout study duration which is a one-year period
|
|
number of patients who succeeded a withdrawal trial
Zeitfenster: throughout study duration which is a one-year period
|
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.
|
throughout study duration which is a one-year period
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2019
Primärer Abschluss (Tatsächlich)
31. Dezember 2019
Studienabschluss (Tatsächlich)
31. August 2021
Studienanmeldedaten
Zuerst eingereicht
11. Januar 2022
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Januar 2022
Zuerst gepostet (Tatsächlich)
27. Januar 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Januar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Januar 2022
Zuletzt verifiziert
1. Januar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HLM_JDR11
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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