Use of High Flows in Pediatric Cardiac Surgical Patients

Congenital Heart Disease Clinical Trial

Official title:

Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01633801
• Other study ID #: BambinoGHRI
• Status: Unknown status
• Phase: N/A
• First received: June 2, 2012
• Last updated: August 21, 2012
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Device:
• Use 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.
• 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.

Locations

Country	Name	City	State
Italy	Francesca Iodice	Rome
Italy	Ospedale Bambino Gesu	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary aim is to verify the reintubation rate between the two groups.	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.