Sedation During Noninvasive Ventilation (NIV)

NCT02264626 | Unknown

• 1 other identifier: 116/2014O
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypercapnic Respiratory Failure

Keywords

acute respiratory failure; noninvasive ventilation; sedation; patient/ventilator interaction

Outcome Measures

Primary Outcomes (3)

• patient-ventilator interaction

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

  one hour

• matching of inspiratory timing

  the patients inspiratory time vs ventilator inspiratory time

  one hour

• Wasted efforts

  breaths unable to trigger the ventilator

  one hour

Secondary Outcomes (1)

• NIV failure

  one hour

Study Arms (1)

acutely ill patients

EXPERIMENTAL

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.

Drug: Remifentanil

Interventions

Remifentanil DRUG

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.

Also known as: ultriva

acutely ill patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients responding well to NIV and not showing signs of poor synchrony

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

San'Orsola Malpighi Hospital, Bologna ITALY

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• stefano nava, md

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

stefano nava, md

CONTACT

393333751828

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory Medicine

Study Record Dates

• First Submitted: October 4, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

IT (1)