Interest of High Flow Nasal Cannula Oxygen Therapy in Ped... | NCT03505814

Studies
Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit

NCT03505814

Sponsor

Hôpital d'enfants Béchir-Hamza

Status

Unknown status

Last Update Posted

Apr 23, 2018Actual

Enrollment

126Estimated

Phase

Not Applicable

Conditions

Weaning Failure

Interventions

High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)
Conventional oxygen therapy

Countries

Tunisia

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

Apr 2018

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

Mar 1, 2017Actual

Primary Completion Date

Aug 31, 2018Estimated

Completion Date

Feb 28, 2019Estimated

First Submitted Date

Apr 3, 2018

First Submission Date that Met QC Criteria

Apr 13, 2018

First Posted Date

Apr 23, 2018Actual

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

Apr 13, 2018

Last Update Posted Date

Apr 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Sonia ben khalifa (PhD), PROFESSOR, Hôpital d'enfants Béchir-HamzaPrincipal Investigator

Lead Sponsor

Hôpital d'enfants Béchir-HamzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment.

Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.

Detailed Description

We conducted a monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included regardless type of admission, severity of disease and randomly assigned in two groups for post-extubation management: Group Optiflow (GO) for patients receiving HNFC oxygen therapy and Control Group (CG) for conventional treatment. Before programmed extubation, newborns and young infants received 0.15 mg/kg of Dexamethasone. Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.

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

126Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optiflow Group	Experimental	high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients.	Device: High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)
Control Group	Active Comparator	Conventional oxygen therapy for post extubation care	Device: Conventional oxygen therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)	Device	High flow and humidified oxygen support for new borns and young infants for post-extubation care	Optiflow Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reintubation rate	need for mechanical ventilation support with tracheal intubation	72 hours following prior weaning and extubation

Secondary Outcomes

Measure	Description	Time Frame
incidence of post-extubation respiratory failure	respiratory failure	72 hours following prior weaning and extubation
time to reintubate	time between first extubation and reintubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

need for mechanical ventilation
tracheal intubation
surgical intensive care admission
availability of extubation criteria

Exclusion Criteria:

prior extubation and mechanical ventilation to the actual episode
weaning failure due to neurological status

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

45 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ben Khalifa Sonia, Pr	Contact	0021698360939		benkhalifa_sonia@yahoo.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital d'Enfants Bechir Hamza	Recruiting	Tunis		1029	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided