Pneumonia ChildhoodNCT03929484
A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula)
A study testing Nasal reservoir cannula in people with Pneumonia Childhood, run by University of California, San Francisco at 1 site in Uganda.
Trial summary
This study evaluates the addition of a novel mask (nasal reservoir cannula) to a standard nasal cannula during supplemental oxygenation for the treatment of hospitalized pediatric patients with hypoxemia due to severe pneumonia. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Pneumonia Childhood
- What is being tested?
- Nasal reservoir cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2017to 31 Mar 2018
- 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 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 1 and ≤ 6 years.
- Severe pneumonia based on WHO criteria
- SpO2 ≥ 85% and < 94% by pulse oximetry on room air
- Hospital admission based on clinician judgment
- Written informed consent from parent(s)/guardian(s) of subjects must be obtained before any study procedure is performed
- Body weight ≥ 8 kg and ≤ 26 kg
Who cannot join
- Hypercapnia (pCO2 > 55 mm Hg or 7.32 kPa) on room air
- Acidosis / lactic acidosis (pH <7.20 and/or lactate >6 mg/dL) on room air
- SpO2 < 85% or ≥ 94% by pulse oximetry on room air
- SICK score > 2.4
- Hemoglobin < 7 g/dL
- Facial abnormalities or trauma precluding use of mask and nasal prongs.
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- Requirement of intubation or non-invasive or invasive positive-pressure ventilation
- Suspected or known pneumothorax
- Body weight < 8 kg or > 26 kg
- Hemodynamic instability based on clinician judgment
- SpO2 < 90% by pulse oximetry on oxygen, measured at the end of the enrollment and before initiation of Period 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula) Plus Nasal Cannula vs. Nasal Cannula Alone for Supplemental Oxygen Delivery in the Treatment of Hospitalized Pediatric Patients With Hypoxemia Due to Severe Pneumonia
This study evaluates the addition of a novel mask (nasal reservoir cannula) to a standard nasal cannula during supplemental oxygenation for the treatment of hospitalized pediatric patients with hypoxemia due to severe pneumonia. Half of patients (Group A) will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula delivery (Period 2). Half of patients (Group B) will receive oxygen for 1 hour using a standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2).
Read the detailed description
Pneumonia is the leading infectious cause of death among children less than 5 years of age. Hypoxemia is a major fatal complication of pneumonia, and the risk of death increases with increasing severity of hypoxemia. Improving oxygen delivery and extending oxygen supplies to children with hypoxemia due to severe pneumonia could reduce mortality in resource-limited settings.
Global Good has developed a low cost oxygen mask (nasal reservoir cannula) to more efficiently deliver oxygen to the pediatric patient by increasing dead space to recapture a portion of expelled oxygen using the spatial distribution of the nasal reservoir cannula volume and length of surface seal. This nasal reservoir cannula fits over a standard nasal cannula (also termed prong). The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
- Conditions
- Pneumonia Childhood
- Being tested
- Nasal reservoir cannula
- Keywords
- Pneumonia, Hypoxemia, Oxygen therapy, Oxygen mask
- Medical subject headings
- Pneumonia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal reservoir cannulaDevice
The experimental oxygen mask (nasal reservoir cannula) fits over a standard nasal cannula. The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Each patient will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula alone (Period 2). Receives: Device: Nasal reservoir cannula |
| Group B | Experimental | Each patient will receive oxygen for 1 hour using a standard nasal cannula alone (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2). Receives: Device: Nasal reservoir cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.
Measured: 1 hour
Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone)
Difference in volume of oxygen used, in liters (from cylinder) Estimation of effect size will help inform the design of a definitive clinical trial.
Measured: 1 hour
Secondary outcomes (6)
Protocol adherence
Proportion of enrolled children who completed the study, per protocol This will help inform the design of a definitive clinical trial.
Measured: 2 hours
Oxygen flow
Average oxygen flow, in liters per minute
Measured: 1 hour
Oxygen saturation (SpO2)
Average continuous oxygen saturation (SpO2) value
Measured: 1 hour
PCO2
PCO2 (capillary blood gas)
Measured: End of each period
pH
pH (capillary blood gas)
Measured: End of each period
Transcutaneous carbon dioxide (tcpCO2)
Average continuous transcutaneous carbon dioxide (tcpCO2) value
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Sep 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Why it stopped: Per sponsor advice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia ChildhoodStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Intellectual Ventures, Makerere University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929484
- Sponsor's protocol ID
- 16-21217
- Status last verified
- Apr 2019
- First submitted
- 2 Mar 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Evaluating a Novel Mask (Nasal Reservoir Cannula) Plus Nasal Cannula vs. Nasal Cannula Alone for Supplemental Oxygen Delivery in the Treatment of Hospitalized Pediatric Patients With Hypoxemia Due to Severe Pneumonia
- ClinicalTrials.gov ID
- NCT03929484
- Acronym / sponsor ID
- 16-21217
- Conditions
- Pneumonia Childhood
- Keywords
- Pneumonia, Hypoxemia, Oxygen therapy, Oxygen mask
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per sponsor advice
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Intellectual Ventures, Makerere University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 26 Apr 2019 (actual)
- 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.
This study evaluates the addition of a novel mask (nasal reservoir cannula) to a standard nasal cannula during supplemental oxygenation for the treatment of hospitalized pediatric patients with hypoxemia due to severe pneumonia. Half of patients (Group A) will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula delivery (Period 2). Half of patients (Group B) will receive oxygen for 1 hour using a standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2).
Detailed description
Pneumonia is the leading infectious cause of death among children less than 5 years of age. Hypoxemia is a major fatal complication of pneumonia, and the risk of death increases with increasing severity of hypoxemia. Improving oxygen delivery and extending oxygen supplies to children with hypoxemia due to severe pneumonia could reduce mortality in resource-limited settings.
Global Good has developed a low cost oxygen mask (nasal reservoir cannula) to more efficiently deliver oxygen to the pediatric patient by increasing dead space to recapture a portion of expelled oxygen using the spatial distribution of the nasal reservoir cannula volume and length of surface seal. This nasal reservoir cannula fits over a standard nasal cannula (also termed prong). The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Nasal reservoir cannulaEach patient will receive oxygen for 1 hour using a novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 1), followed by a 1-hour period of continued use of the standard nasal cannula alone (Period 2). |
| Group B | Experimental | Device: Nasal reservoir cannulaEach patient will receive oxygen for 1 hour using a standard nasal cannula alone (Period 1), followed by a 1-hour period of continued use of the novel mask (nasal reservoir cannula) plus standard nasal cannula (Period 2). |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ≥ 1 and ≤ 6 years.
- Severe pneumonia based on WHO criteria
- SpO2 ≥ 85% and < 94% by pulse oximetry on room air
- Hospital admission based on clinician judgment
- Written informed consent from parent(s)/guardian(s) of subjects must be obtained before any study procedure is performed
Key exclusion criteria (11 listed)
- Hypercapnia (pCO2 > 55 mm Hg or 7.32 kPa) on room air
- Acidosis / lactic acidosis (pH <7.20 and/or lactate >6 mg/dL) on room air
- SpO2 < 85% or ≥ 94% by pulse oximetry on room air
- SICK score > 2.4
- Hemoglobin < 7 g/dL
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 |
|---|---|---|
| Nasal reservoir cannulaThe experimental oxygen mask (nasal reservoir cannula) fits over a standard nasal cannula. The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone. | Device | Group A, Group B |
Primary outcome
Recruitment rate
Time frame: 1 hour
Proportion of screened children who were enrolled This will help inform the design of a definitive clinical trial.
Estimated effect of novel mask on amount of oxygen used (compared to standard nasal cannula alone)
Time frame: 1 hour
Difference in volume of oxygen used, in liters (from cylinder) Estimation of effect size will help inform the design of a definitive clinical trial.
6 secondary outcomes
Protocol adherence
Time frame: 2 hours
Oxygen flow
Time frame: 1 hour
Oxygen saturation (SpO2)
Time frame: 1 hour
PCO2
Time frame: End of each period
pH
Time frame: End of each period
Transcutaneous carbon dioxide (tcpCO2)
Time frame: 1 hour
Results and safety
The study was stopped early (reason given: Per sponsor advice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal reservoir cannula in people with Pneumonia Childhood, run by University of California, San Francisco at 1 site in Uganda.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
The study was stopped early (reason given: Per sponsor advice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2019.