Sedation During Noninvasive Ventilation (NIV)

Study Overview
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Brief Summary
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In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure. This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing. The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV.

Detailed Description
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In patients undergoing NIV for acute respiratory, lack of tolerance is one of the main reason of failure. This may result in a poor synchrony between the patient and the machine, leading to gross mismatching and potentially to an increased work of breathing. The investigators aim to investigate whether in these patients poorly responding to NIV the use of a sedation protocol using remifentanil will lead to an improve patient-ventilator interaction and better compliance to NIV. In this physiological study the investigators will study 15 patients at risk of failing NIV because of scarce tolerance and showing clinical signs of poor interaction with the ventilator. Once the patient will be enrolled the investigators will record using the balloon-catheter technique the online measurement of respiratory mechanics, to assess the inspiratory muscle effort and the matching between the patient breathing pattern and that of the ventilator The investigators will also record the clinical success of sedation (i.e. need or not for endotracheal intubation)

Official Title
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Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)

Conditions
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Acute Hypercapnic Respiratory Failure

Intervention / Treatment
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* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ph<7,35 and PaCO2>50 mmHg with acute respiratory failure Signs of respiratory distress and poor synchrony with the ventilator as assessed on the ventilator screen and by looking patient own rate and ventilator recorded rate Exclusion Criteria: Patients responding well to NIV and not showing signs of poor synchrony

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acutely ill patients<br>administration of remifentanil at the infusion rate by 0.025 μg kg-1 min-1 to a maximum of 0.10 μg kg-1 min-1. | Drug: Remifentanil<br>* infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.<br>* Other names: ultriva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-ventilator interaction | patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify | one hour | 
| matching of inspiratory timing | the patients inspiratory time vs ventilator inspiratory time | one hour | 
| Wasted efforts | breaths unable to trigger the ventilator | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIV failure | failure will be defined as the need for intubation: gasping for air worsening of sensorium respiratory arrest retention of secretions and/ or death | one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute respiratory failure, noninvasive ventilation, sedation, patient/ventilator interaction