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Use of 4 different machines in patients with a significant drop in blood oxygen levels even on minimum exertion.

A randomized, controlled, single-blind, four-period crossover trial comparing no oxygen, conventional continuous-flow oxygen, pulsed variable-flow oxygen, and pulsed constant-flow oxygen during 6-Minute and 12-Minute Walk Tests in adults with exertional hypoxemia. - CORE Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112006
Enrollment
48
Registered
2026-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: Nil: Nil Intervention2: No oxygen (Sham device present but no flow) o B) Continuous-Flow Oxygen (CFO) o C) Pulsed Variable-Flow Oxygen (PVO) o D) Pulsed Constant-Flow Oxygen (PCO) : E

Sponsors

Sanrai Med India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Able to ambulate independently have chronic lung disease have confirmed exertional hypoxemia Resting Spo2 is more than equal to 94 percent.

Exclusion criteria

Exclusion criteria: unstable cardiac disease not giving consent pregnancy requiring long term oxygen at rest

Design outcomes

Primary

MeasureTime frame
-Minute Walk Distance (6MWD) On-Oxygen vs. Off-Oxygen: Comparison of distance walked (meters) during the 6MWT performed on the active device vs. the paired 6MWT performed off-oxygen within the same visit. 2.12-Minute Walk Distance (12MWD) On-Oxygen vs. Off-Oxygen (Sham): Comparison of distance walked (meters) during the 12MWT performed on the active device vs. the 12MWT performed off-oxygen (sham) from another visit.Timepoint: -Minute Walk Distance (6MWD) On-Oxygen vs. Off-Oxygen: Comparison of distance walked (meters) during the 6MWT performed on the active device vs. the paired 6MWT performed off-oxygen within the same visit. 2.12-Minute Walk Distance (12MWD) On-Oxygen vs. Off-Oxygen (Sham): Comparison of distance walked (meters) during the 12MWT performed on the active device vs. the 12MWT performed off-oxygen (sham) from another visit.—

Secondary

MeasureTime frame
Symptoms: Borg CR10 Dyspnea and Leg Fatigue at the end of each test.Timepoint: 12 months—

Countries

India

Contacts

Public ContactDr Raja Dhar

The Calcutta Medical Research Institute

pulmoresearch@gmail.com09831855512

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026