Intrinsieke ademhalingsfrequentiebeoordeling tijdens mechanische ventilatie om spontane ademhaling en extubatie te versnellen (INTRINSIC)
Beoordeling van de intrinsieke ademhalingsfrequentie bij mechanisch beademde volwassen patiënten met omgekeerde triggering als stimulans voor het versnellen van de overgang naar spontane ademhaling en extubatie: gerandomiseerde klinische pilotstudie - INTRINSIC
The goal of this study is to identify patients with reverse triggering who's the potential to breath spontaneously is hidden because of the ventilator management strategy by performing a simple 30sec-test with includes reducing the support from the ventilator. The findings will provide clear advice to doctors on how to better care for these patients.
This will be a pilot randomized clinical trial including 70 adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering. The study will be conducted in two ICUs: 1) St. Michael's Hospital, Toronto Canada and 2) Toronto Western Hospital, Toronto, Canada.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The objective of this study is to investigate the impact of assessing intrinsic respiratory rate in mechanically ventilated patients with reverse triggering on the facilitation of transition to spontaneous breathing and successful extubation.
Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25 at the time of study procedure.
Patients will be screened every morning from 8:00 am to 9:00 am all the patients under controlled ventilation to detect the presence of reverse triggering by looking at the screen on the ventilator (2-5 min observation). The research team (research MDs, physiotherapists and respiratory therapists) is very well trained at detecting reverse triggering. Patients will then be randomized to standard of care or intervention using a deferred consent model.
- Control group: standard care.
- Intervention group: The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.
If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:
- It will be indicated that the patient tolerated 5 min of pressure support ventilation and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Laurent Brochard, MD
- Telefoonnummer: 4168645686
- E-mail: laurent.brochard@unityhealth.to
Studie Contact Back-up
- Naam: Antenor Rodrigues, Ph.D.
- E-mail: antenor.rodrigues@unityhealth.to
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5B1W8
- Werving
- St. Michael's Hospital
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Contact:
- Nattapat Wongtirawit, M.D.
- Telefoonnummer: 6214 416-864-6060
- E-mail: nattapat.wongtirawit@unityhealth.to
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Toronto, Ontario, Canada
- Nog niet aan het werven
- Toronto Western Hospital
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Contact:
- Irene Telias, MD, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering.
Exclusion Criteria:
- under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25) at the time of study procedure.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Standard Care
The participant will receive the current standard intensive care. |
|
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Actieve vergelijker: brief test
The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate. If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed: - It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation. |
The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate. If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed: - It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours
Tijdsspanne: 48 hours
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Number of patients tolerating the transition to assisted breathing (e.g., Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, Proportional assist ventilation with load-adjustable gain factors), or having an SBT, or being extubated within 48 hours |
48 hours
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Laurent Brochard, Unity Health Toronto - St. Michael's Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
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Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 4902
Informatie over medicijnen en apparaten, studiedocumenten
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