Use of High Flows in Pediatric Cardiac Surgical Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Bambino Gesù Hospital and Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Francesca Giovanna Iodice, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT01633801
First received: June 2, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Congenital Heart Disease
Device: Use of high flows versus oxygen therapy
Device: oxygen therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients

Resource links provided by NLM:


Further study details as provided by Bambino Gesù Hospital and Research Institute:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High flows 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.
Other Names:
  • high flow nasal cannulae
  • (via Neonatal Nasal Cannula- Fisher & Paykel)
Device: 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 Name: traditional nasal cannulae
oxygen therapy Device: 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 Name: traditional nasal cannulae

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.

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633801

Locations
Italy
Ospedale Bambino Gesu Recruiting
Rome, Italy, 00165
Contact: Francesca G Iodice, M.D.    0039066859 ext 2449    francesca_iodice@yahoo.it   
Principal Investigator: Francesca Iodice, M.D.         
Francesca Iodice Recruiting
Rome, Italy, 00195
Contact: Francesca Iodice, MD    393336545045    fgiovanna.iodice@opbg.net   
Contact: Francesca Iodice    393336545045    francesca_iodice@yahoo.it   
Sub-Investigator: Giuseppina Testa, MD         
Sub-Investigator: Vincenzo Vitale, MD         
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
Principal Investigator: Francesca Iodice, MD Ospedale Bambino Gesu'
  More Information

No publications provided

Responsible Party: Francesca Giovanna Iodice, Doctor in Medicine, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT01633801     History of Changes
Other Study ID Numbers: BambinoGHRI
Study First Received: June 2, 2012
Last Updated: August 21, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014