Congenital Heart Disease
Conditions
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.
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.
Interventions
DEVICEUse of high flows versus 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.
DEVICEoxygen therapy
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Sponsors
Bambino Gesù Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Italy
Outcome results
None listed