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Testing of a new oxygen device with pressure valve (Positive expiratory pressure - oxygen therapy) in older children and adults with breathing difficulty.

Positive Expiratory Pressure- Oxygen Therapy (PEP-OT) for respiratory distress in older children and adults

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029679
Enrollment
25
Registered
2020-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: J09-J18- Influenza and pneumonia Health Condition 2: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: Positive expiratory pressure - oxygen therapy trial: Duration of therapy: 45 minutes. Patients on standard oxygen therapy will be put on positive expiratory pressure-oxygen therapy sup

Sponsors

AIIMS Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients, aged 10-55 years on standard oxygen therapy for at least 1 hour with features of respiratory distress, with stability on current support. Respiratory distress defined as either of following: 1. Respiratory rate � 24/minute 2. SpO2 at current support 3. Features of accessory muscle use (intercostal retractions, nasal flaring)

Exclusion criteria

Exclusion criteria: 1. Acute exacerbation of asthma or chronic obstructive pulmonary disease. 2. Impending respiratory failure (features of exhaustion, or SpO2 3. Poor respiratory efforts (muscular weakness, or reduced central drive) 4. Patients with chronic or acute hypercapnia (PaCO2 >45) 5. Hemodynamically unstable (Hypotension or requirement of inotropic support) 6. Altered sensorium (Glasgow Coma Scale < 15)

Design outcomes

Primary

MeasureTime frame
Proportions of patients tolerating PEP-OTTimepoint: At 15 minutes, 30 minutes and 45 minutes of PEP-OT

Secondary

MeasureTime frame
Change in respiratory and cardiovascular parameters after starting PEP-OTTimepoint: every 15 minutes over 45 minutes of PEP-OT trial, followed by 15 minutes following completion of PEP-OT trial;Incidence of adverse events of PEP-OTTimepoint: continuously over 45 minutes of PEP-OT trial and 15 minutes following PEP-OT trial

Countries

India

Contacts

Public ContactRakesh Lodha

AIIMS, Delhi

rlodha1661@gmail.com01126593621

Outcome results

None listed

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