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

NCT ID: NCT03505814

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-02-28

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.

Conditions

Weaning Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Optiflow Group

high flow (6l/min), humidified oxygen administred into nasal cannula for post-extubation new born ventilated patients.

Group Type: EXPERIMENTAL

High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)

Intervention Type: DEVICE

High flow and humidified oxygen support for new borns and young infants for post-extubation care

Control Group

Conventional oxygen therapy for post extubation care

Group Type: ACTIVE_COMPARATOR

Conventional oxygen therapy

Intervention Type: DEVICE

conventional oxygen support for new born and young infants in post-extubation care

Interventions

High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)

High flow and humidified oxygen support for new borns and young infants for post-extubation care

Intervention Type: DEVICE

Conventional oxygen therapy

conventional oxygen support for new born and young infants in post-extubation care

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 45 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital d'enfants Béchir-Hamza

OTHER

Sponsor Role: lead

Responsible Party

Dr Sonia ben khalifa (PhD)

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hopital d'Enfants Bechir Hamza

Tunis, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Ben Khalifa Sonia, Pr

Role: CONTACT

benkhalifa_sonia@yahoo.fr

0021698360939

Facility Contacts

Benkhalifa Sonia, Pr

Role: primary

benkhalifa_sonia@yahoo.fr

0021698360939

Other Identifiers

HEBechirHamza

Identifier Type: -

Identifier Source: org_study_id