Sedation During Noninvasive Ventilation (NIV)

Not Applicable

• Conditions: Acute Hypercapnic Respiratory Failure
• Interventions: Drug: Remifentanil

• Registration Number: NCT02264626
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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)

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-04
• Study First Submitted QC: 2014-10-14
• Study First Posted: 2014-10-15
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-08
• Last Update Posted: 2016-10-11
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acutely ill patients	Remifentanil	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
NIV failure	one hour	failure will be defined as the need for intubation: * gasping for air; * worsening of sensorium; * respiratory arrest; * retention of secretions and/ or death

Trial Locations

Locations (1)

San'Orsola Malpighi Hospital, Bologna ITALY; 🇮🇹 Bologna, Italy