Sedation During Noninvasive Ventilation (NIV)

Acute Hypercapnic Respiratory Failure Clinical Trial

— REMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264626
• Other study ID #: 116/2014O
• Status: Recruiting
• Phase: N/A
• First received: October 4, 2014
• Last updated: October 8, 2016
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: October 2016
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: stefano nava, md
• Phone: 393333751828
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

Intervention

Drug:
• Remifentanil
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.

Locations

Country	Name	City	State
Italy	San'Orsola Malpighi Hospital, Bologna ITALY	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-ventilator interaction	patient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify	one hour	No
Primary	matching of inspiratory timing	the patients inspiratory time vs ventilator inspiratory time	one hour	No
Primary	Wasted efforts	breaths unable to trigger the ventilator	one hour	No
Secondary	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	No