Investigating the safety and oxygen-savings of a new nasal cannula used to treat severe pneumonia in children in low-resource settings

Oxygen sparing and clinical safety of nasal reservoir cannula for the treatment of pediatric hypoxemic pneumonia in a low-resource setting

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15216845

Enrollment

Registered

2020-07-15

Start date

2018-11-20

Completion date

Unknown

Last updated

2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemic pneumonia Respiratory Hypoxemic pneumonia in children. Pneumonia, organism unspecified.

Interventions

The study will test an oxygen-sparing reservoir cannula which fits over a standard nasal cannula and increases dead space to recapture a portion of expelled oxygen. This will be compared to the use of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =1 year and =6 years 2. Severe pneumonia based on World Health Organization (WHO) criteria 2 3. SpO2 =85% and <94% by pulse oximetry on room air 4. Hospital admission indicated based on clinician judgment 5. Body weight =8 kg and =26 kg

Exclusion criteria

Exclusion criteria: 1. Hypercapnia (pCO2 >55 mmHg) on room air 2. pH 3 mmol/l (capillary blood gas) 4. SICK score 20 > 2.4 5. Hemoglobin <7 g/dl 6. Facial abnormalities or trauma precluding use of nasal prongs 7. Requiring intubation or positive-pressure ventilation 8. Suspected or known pneumothorax 9. Hemodynamic instability 10. Failure to respond to oxygen after trial period (SpO2 <90%, measured after 10 mins of oxygen therapy at 2 l/min)

Design outcomes

Primary

Measure	Time frame
Clinical safety of the reservoir cannula (RC) was assessed using CO2 retention, as measured by the change in pCO2 on capillary blood gas measurement after 1 h on RC or standard nasal cannula (SNC). The change was calculated using measurements taken at baseline and 1 hour later.	—

Secondary

Measure	Time frame
1. Incidence of clinical adverse events, including: pCO2 above the normal range (>45 mmHg); lactate above the normal range (>3 mmol/l); acidosis (pH <7.35); and refractory hypoxemia (SpO2 <90%) despite supplemental oxygen therapy at any time on RC, measured from capillary blood gas at baseline, 1, and 2 h 2. Longitudinal changes in pCO2, pH, and lactate measured from capillary blood gas at baseline, 1, and 2 h 3. RC efficacy measured using oxygen utilization and SpO2 (using a finger pulse oximeter) at several O2 flow rates on either RC or standard nasal cannula (SNC) alone, at baseline, 1, and 2 h	—

Measure

Time frame

1. Incidence of clinical adverse events, including: pCO2 above the normal range (>45 mmHg); lactate above the normal range (>3 mmol/l); acidosis (pH <7.35); and refractory hypoxemia (SpO2 <90%) despite supplemental oxygen therapy at any time on RC, measured from capillary blood gas at baseline, 1, and 2 h 2. Longitudinal changes in pCO2, pH, and lactate measured from capillary blood gas at baseline, 1, and 2 h 3. RC efficacy measured using oxygen utilization and SpO2 (using a finger pulse oximeter) at several O2 flow rates on either RC or standard nasal cannula (SNC) alone, at baseline, 1, and 2 h

—

Countries

Uganda

Contacts

Public ContactMichael Hawkes

mthawkes@ualberta.ca+1-780-248-5540

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026