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Use of High Flows in Pediatric Cardiac Surgical Patients

Primary Purpose

Congenital Heart Disease

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Use of high flows versus oxygen therapy
oxygen therapy
Sponsored by
Bambino Gesù Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

1 Day - 18 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Bambino GesuRecruiting
  • Francesca IodiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High flows

oxygen therapy

Arm Description

Outcomes

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 2, 2012
Last Updated
August 21, 2012
Sponsor
Bambino Gesù Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01633801
Brief Title
Use of High Flows in Pediatric Cardiac Surgical Patients
Official Title
Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bambino Gesù Hospital and Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High flows
Arm Type
Other
Arm Title
oxygen therapy
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Use of high flows versus oxygen therapy
Other Intervention Name(s)
high flow nasal cannulae, (via Neonatal Nasal Cannula- Fisher & Paykel)
Intervention Description
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Intervention Type
Device
Intervention Name(s)
oxygen therapy
Other Intervention Name(s)
traditional nasal cannulae
Intervention Description
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
The secondary aim is to verify the reintubation rate between the two groups.
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Iodice, MD
Organizational Affiliation
Ospedale Bambino Gesu'
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Bambino Gesu
City
Rome
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca G Iodice, M.D.
Phone
0039066859
Ext
2449
Email
francesca_iodice@yahoo.it
First Name & Middle Initial & Last Name & Degree
Francesca Iodice, M.D.
Facility Name
Francesca Iodice
City
Rome
ZIP/Postal Code
00195
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Iodice, MD
Phone
393336545045
Email
fgiovanna.iodice@opbg.net
First Name & Middle Initial & Last Name & Degree
Francesca Iodice
Phone
393336545045
Email
francesca_iodice@yahoo.it
First Name & Middle Initial & Last Name & Degree
Giuseppina Testa, MD
First Name & Middle Initial & Last Name & Degree
Vincenzo Vitale, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24912486
Citation
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.
Results Reference
derived

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Use of High Flows in Pediatric Cardiac Surgical Patients

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