NCT01633801

Brief Summary

Humidified high flow nasal prong oxygen therapy is a method for providing oxygen and CPAP. The delivery of high flows decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase. In addition, a flow-dependent effect of continuous positive airway pressure, possibly due to an air entrainment mechanism, has been documented in healthy volunteers and in patients with COPD. The investigators working hypothesis is that the use of post-extubation CPAP delivered via nasal cannulae in infants less than 18 months, post-bypass surgery will have better PaCO2 values than infants extubated on to oxygen therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
28 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

June 2, 2012

Last Update Submit

August 21, 2012

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • The primary aim of this study is to show an improvement of the average levels of postextubation PaCO2 in infants less than 18 months of age and post-bypass surgery

    Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.

Secondary Outcomes (1)

  • The secondary aim is to verify the reintubation rate between the two groups.

    Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.

Study Arms (2)

High flows

OTHER
Device: Use of high flows versus oxygen therapyDevice: oxygen therapy

oxygen therapy

OTHER
Device: oxygen therapy

Interventions

Use of high flows versus oxygen therapyDEVICE

Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.

Also known as: high flow nasal cannulae, (via Neonatal Nasal Cannula- Fisher & Paykel)
High flows
oxygen therapyDEVICE

Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.

Also known as: traditional nasal cannulae
High flowsoxygen therapy

Eligibility Criteria

Age1 Day - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 0-18 months
  • Mechanical Ventilation via an endotracheal tube
  • Elective surgery
  • Post-bypass procedure
  • Rachs 2 and above

You may not qualify if:

  • Presence of major congenital malformations
  • Presence of neuromuscular disease
  • Presence of non drained pneumothorax
  • Absent respiratory drive or recurrent apneas
  • Hemodynamic instability
  • Glasgow coma score (GCS) less than 8
  • ECG with evidence of ischaemia or arrhythmias
  • Active bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Francesca Iodice

Rome, Italy, 00195, Italy

RECRUITING

Ospedale Bambino Gesu

Rome, 00165, Italy

RECRUITING

Related Publications (1)

  • Testa G, Iodice F, Ricci Z, Vitale V, De Razza F, Haiberger R, Iacoella C, Conti G, Cogo P. Comparative evaluation of high-flow nasal cannula and conventional oxygen therapy in paediatric cardiac surgical patients: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2014 Sep;19(3):456-61. doi: 10.1093/icvts/ivu171. Epub 2014 Jun 8.

    PMID: 24912486DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Francesca Iodice, MD

    Ospedale Bambino Gesu'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor in Medicine

Study Record Dates

First Submitted

June 2, 2012

First Posted

July 4, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

IT(2)