- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01633801
Use of High Flows in Pediatric Cardiac Surgical Patients
Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After CICU admission, infants with no bleeding, normothermic and hemodynamically stable will be switched from PRVC to SIMV+PSV (10-15cmH20) which should be maintained for 4 hours. An arterial gas analysis will be performed after 20 minutes. Infants with normal gas-exchange are gradually weaned from mechanical ventilation At each weaning step an arterial hemogasanalysis is performed after 20 minutes, to assess if the decreased ventilatory support is tolerated. Increased work of breathing and respiratory acidosis (ph< 7.3 or pCO2 > 60 mmHg) are considered criteria to withhold the weaning process. After a 4 hour period on SIMV+PSV the child should be switched to PSV for 30 minutes and then extubated. The following extubation criteria should be reached:
- Satisfactory blood gases with PCO2 under 45mmHg, pH greater than 7.30.
- Fractional inspired oxygen concentration of 65% and or less than the baseline value
- Adequate respiratory frequency according to age without dyspnea
At this point criteria for extubation are reached. Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rome, Italy, 00165
- Recruiting
- Ospedale Bambino Gesu
-
Contact:
- Francesca G Iodice, M.D.
- Phone Number: 2449 0039066859
- Email: francesca_iodice@yahoo.it
-
Principal Investigator:
- Francesca Iodice, M.D.
-
Rome, Italy, 00195
- Recruiting
- Francesca Iodice
-
Contact:
- Francesca Iodice, MD
- Phone Number: 393336545045
- Email: fgiovanna.iodice@opbg.net
-
Contact:
- Francesca Iodice
- Phone Number: 393336545045
- Email: francesca_iodice@yahoo.it
-
Sub-Investigator:
- Giuseppina Testa, MD
-
Sub-Investigator:
- Vincenzo Vitale, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 0-18 months
- Mechanical Ventilation via an endotracheal tube
- Elective surgery
- Post-bypass procedure
- Rachs 2 and above
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: High flows
|
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Other Names:
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Other Names:
|
Other: oxygen therapy
|
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary aim is to verify the reintubation rate between the two groups.
Time Frame: 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.
|
Other points that will be evaluated are: the improvement of X-ray findings, the length of ICU stay and the development of complications such as nasal ulcers and gastric distension.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Francesca Iodice, MD, Ospedale Bambino Gesu'
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BambinoGHRI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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