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Sedation During Noninvasive Ventilation (NIV)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02264626
Acronym
REMI
Enrollment
15
Registered
2014-10-15
Start date
2014-10-31
Completion date
2017-10-31
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure

Keywords

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

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)

Interventions

DRUGRemifentanil

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.

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patient-ventilator interactionone hourpatient-ventilator interaction will be assessed using the recording of respiratory mechanics to identify
matching of inspiratory timingone hourthe patients inspiratory time vs ventilator inspiratory time
Wasted effortsone hourbreaths unable to trigger the ventilator

Secondary

MeasureTime frameDescription
NIV failureone hourfailure will be defined as the need for intubation: * gasping for air * worsening of sensorium * respiratory arrest * retention of secretions and/ or death

Countries

Italy

Contacts

Primary Contactstefano nava, md
393333751828

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026