Sedation During Noninvasive Ventilation (NIV) | NCT02264626

Studies
Sedation During Noninvasive Ventilation (NIV)

NCT02264626

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Status

Unknown status

Last Update Posted

Oct 11, 2016Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Acute Hypercapnic Respiratory Failure

Interventions

Remifentanil

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Oct 4, 2014

First Submission Date that Met QC Criteria

Oct 14, 2014

First Posted Date

Oct 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2016

Last Update Posted Date

Oct 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

dr. Stefano Nava, Professor of Respiratory Medicine, IRCCS Azienda Ospedaliero-Universitaria di BolognaPrincipal Investigator

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	acutely ill patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
stefano nava, md	Contact	393333751828

Overall Officials

Name	Affiliation	Role
stefano nava, md	IRCCS Azienda Ospedaliero-Universitaria di Bologna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San'Orsola Malpighi Hospital, Bologna ITALY	Recruiting	Bologna		40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided