Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation (DEX-PCH-VMNI)
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|ClinicalTrials.gov Identifier: NCT02958150|
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure||Drug: Dexmedetomidine Procedure: Standard Clinical Practice||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Dexmedetomidine according to the stablished protocol
Active Comparator: Standard Clinical Practice
The physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department
Procedure: Standard Clinical Practice
- To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial. [ Time Frame: 72 hours ]Need for intubation is defined as the presence of any of the following: SpO2<80% or P aO2/FiO2<150, seizures, poor secretion management, hypercapnia and pH<7.20, hypotension: systolic blood pressure (SBP)<80 mmHg refractory despite administration of vasoactive amines or electrocardiogram (ECG) with ischaemic changes or ventricular arrhythmia resulting from myocardial hypoxia.
- To determinate NIV duration of NIV in each group. [ Time Frame: 72 hours ]Number of hours the patient will be on NIV.
- To analyse stay at the ICU in each group. [ Time Frame: An average of 5 days ]Number of days patients stay at the ICU until they are discharged home or die.
- To analyse hospital stay in each group [ Time Frame: 15 days ]Number of days patients remain at the hospital until they are discharged home or die.
- To compare all-cause mortality at the ICU in both groups. [ Time Frame: Through study completion, an average of 3 years ]Percentage of all deaths from any cause in patients with ARF on NIV at the ICU in both study groups.
- To compare specific mortality at the ICU in both groups. [ Time Frame: Through study completion, an average of 3 years ]Percentage of deaths attributable to ARF in patients on NIV at the ICU in both study groups.
- To analyse hospital-specific mortality. [ Time Frame: Through study completion, an average of 3 years ]Percentage of all deaths attributable to ARF in patients on NIV at the ICU discharged to a ward in the 2 study groups.
- To analyse all-cause hospital mortality. [ Time Frame: Through study completion, an average of 3 years ]Percentage of all deaths from any aetiology of ARF in patients treated with NIV in the ICU discharged to a ward in the 2 study groups.
- To report the course of ARF in each group. [ Time Frame: 1 and 24 hours after NIV ]Based on the presence before the start of NIV
- To report NIV tolerance during administration of dexmedetomidine versus SCP. [ Time Frame: During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed. ]Nausea and/or vomiting, Aspiration pneumonia, delirium, agitation, interface tolerance or pain secondary to use of interface.
- To report the adverse effects of dexmedetomidine. [ Time Frame: During drug administration and up to 24 hours after drug infusion is completed. ]Bradycardia, hypotension, tachycardia, hypertension and/or transient respiratory depression.
- To asses patient satisfaction with dexmedetomidine as compared to SCP [ Time Frame: Through study completion, an average of 3 years ]Patient satisfaction with use of dexmedetomidine as compared to drugs used in SCP will be estimated once NIV and dexmedetomidine/SCP infusion have been completed, using a Likert type questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958150
|Contact: Ana Vallejo||945007280||ANA.VALLEJODELACUEVA@osakidetza.eus|
|Araba University Hospital||Recruiting|
|Vitoria, Álava, Spain, 01009|
|Contact: Ana Vallejo 945007280 ANA.VALLEJODELACUEVA@osakidetza.eus|
|Principal Investigator:||Ana Vallejo||Basque Health Service: Araba University Hospital|