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Sedation During Noninvasive Ventilation (NIV) (REMI)

Primary Purpose

Acute Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure focused on measuring acute respiratory failure, noninvasive ventilation, sedation, patient/ventilator interaction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San'Orsola Malpighi Hospital, Bologna ITALYRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

acutely ill patients

Arm Description

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.

Outcomes

Primary Outcome Measures

patient-ventilator interaction
patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
matching of inspiratory timing
the patients inspiratory time vs ventilator inspiratory time
Wasted efforts
breaths unable to trigger the ventilator

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2014
Last Updated
October 8, 2016
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02264626
Brief Title
Sedation During Noninvasive Ventilation (NIV)
Acronym
REMI
Official Title
Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypercapnic Respiratory Failure
Keywords
acute respiratory failure, noninvasive ventilation, sedation, patient/ventilator interaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acutely ill patients
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
ultriva
Intervention Description
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.
Primary Outcome Measure Information:
Title
patient-ventilator interaction
Description
patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
Time Frame
one hour
Title
matching of inspiratory timing
Description
the patients inspiratory time vs ventilator inspiratory time
Time Frame
one hour
Title
Wasted efforts
Description
breaths unable to trigger the ventilator
Time Frame
one hour
Secondary Outcome Measure Information:
Title
NIV failure
Description
failure will be defined as the need for intubation: gasping for air worsening of sensorium respiratory arrest retention of secretions and/ or death
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stefano nava, md
Phone
393333751828
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stefano nava, md
Organizational Affiliation
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
San'Orsola Malpighi Hospital, Bologna ITALY
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
Phone
051 6364017
Email
stefano.nava@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD

12. IPD Sharing Statement

Learn more about this trial

Sedation During Noninvasive Ventilation (NIV)

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