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Use of High Flows in Pediatric Cardiac Surgical Patients

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ClinicalTrials.gov Identifier: NCT01633801
Recruitment Status : Unknown
Verified August 2012 by Francesca Giovanna Iodice, Bambino Gesù Hospital and Research Institute.
Recruitment status was:  Recruiting
First Posted : July 4, 2012
Last Update Posted : August 22, 2012
Sponsor:
Information provided by (Responsible Party):
Francesca Giovanna Iodice, Bambino Gesù Hospital and Research Institute

Tracking Information
First Submitted Date  ICMJE June 2, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date August 22, 2012
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2012)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of High Flows in Pediatric Cardiac Surgical Patients
Official Title  ICMJE Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • High flows
    Interventions:
    • Device: Use of high flows versus oxygen therapy
    • Device: oxygen therapy
  • oxygen therapy
    Intervention: Device: oxygen therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 2, 2012)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633801
Other Study ID Numbers  ICMJE BambinoGHRI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesca Giovanna Iodice, Bambino Gesù Hospital and Research Institute
Study Sponsor  ICMJE Bambino Gesù Hospital and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesca Iodice, MD Ospedale Bambino Gesu'
PRS Account Bambino Gesù Hospital and Research Institute
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP