Congenital Heart DiseaseNCT01633801
Use of High Flows in Pediatric Cardiac Surgical Patients
A study testing Use of high flows versus oxygen therapy and oxygen therapy in people with Congenital Heart Disease, run by Bambino Gesù Hospital and Research Institute at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Use of high flows versus oxygen therapy and oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 0-18 months
- Mechanical Ventilation via an endotracheal tube
- Elective surgery
- Post-bypass procedure
- Rachs 2 and above
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Francesca Iodice
Rome, Italy, 00195
Francesca Iodice, MD, 393336545045, fgiovanna.iodice@opbg.net
Francesca Iodice, 393336545045, francesca_iodice@yahoo.it
- Recruiting
Ospedale Bambino Gesu
Rome, 00165
Francesca G Iodice, M.D., 0039066859 ext. 2449, francesca_iodice@yahoo.it
Francesca Iodice, M.D.
About this study
Official title: Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Use of high flows versus oxygen therapy, oxygen therapy
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of high flows versus oxygen therapyDevice
Also called high flow nasal cannulae, (via Neonatal Nasal Cannula- Fisher & Paykel)
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
oxygen therapyDevice
Also called traditional nasal cannulae
Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
| Study group | Role | What they receive |
|---|---|---|
| High flows | Other | Not described Receives: Device: Use of high flows versus oxygen therapy; Device: oxygen therapy |
| oxygen therapy | Other | Not described Receives: Device: oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Giovanna Iodice, Bambino Gesù Hospital and Research Institute
- Investigators
- Francesca Iodice, MD, Principal investigator, Ospedale Bambino Gesu'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633801
- Sponsor's protocol ID
- BambinoGHRI
- Status last verified
- Aug 2012
- First submitted
- 2 Jun 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24912486
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Flow Ventilation in Pediatric Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT01633801
- Acronym / sponsor ID
- BambinoGHRI
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flows | Other | Device: Use of high flows versus oxygen therapy, Device: oxygen therapy |
| oxygen therapy | Other | Device: oxygen therapy |
Who may qualify
- Ages
- 1 day to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 0-18 months
- Mechanical Ventilation via an endotracheal tube
- Elective surgery
- Post-bypass procedure
- Rachs 2 and above
Key exclusion criteria (8 listed)
- Presence of major congenital malformations
- Presence of neuromuscular disease
- Presence of non drained pneumothorax
- Absent respiratory drive or recurrent apneas
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of high flows versus oxygen therapyAlso: high flow nasal cannulae, (via Neonatal Nasal Cannula- Fisher & Paykel)Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization. | Device | High flows |
| oxygen therapyAlso: traditional nasal cannulaeOnce extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization. | Device | High flows, oxygen therapy |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- Derived from this study: PubMed 24912486Testa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Iodice, MD principal investigator
Ospedale Bambino Gesu'
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of high flows versus oxygen therapy and oxygen therapy in people with Congenital Heart Disease, run by Bambino Gesù Hospital and Research Institute at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.