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Clinical Trials/NCT02264626
NCT02264626
Unknown
Not Applicable

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country15 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Remifentanil
Conditions
Acute Hypercapnic Respiratory Failure
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
15
Locations
1
Primary Endpoint
patient-ventilator interaction
Last Updated
9 years ago

Overview

Brief Summary

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

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)

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

dr. Stefano Nava

Professor of Respiratory Medicine

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility Criteria

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

Arms & Interventions

acutely ill patients

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.

Intervention: Remifentanil

Outcomes

Primary Outcomes

patient-ventilator interaction

Time Frame: one hour

patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify

Wasted efforts

Time Frame: one hour

breaths unable to trigger the ventilator

matching of inspiratory timing

Time Frame: one hour

the patients inspiratory time vs ventilator inspiratory time

Secondary Outcomes

  • NIV failure(one hour)

Study Sites (1)

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