Clinical trial NCT02264626: Sedation During Noninvasive Ventilation (NIV)
Official title: Effects of Remifentanil Based Sedation on Patient-ventilator Interaction, in Patients Undergoing Noninvasive Ventilation (NIV)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Hypercapnic Respiratory Failure
Keywords: acute respiratory failure
noninvasive ventilation
sedation
patient/ventilator interaction
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2014-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: patient-ventilator interaction
timeFrame: one hour
measure: matching of inspiratory timing
timeFrame: one hour
measure: Wasted efforts
timeFrame: one hour
Secondary outcomes:
measure: NIV failure
timeFrame: one hour
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: San'Orsola Malpighi Hospital, Bologna ITALY
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: stefano nava, md
role: PRINCIPAL_INVESTIGATOR
References: