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A clinical study to evaluate heat and moisture exchangers and breathing system filters that are intended to replace the normal warming, humidifying and filtering functions of the upper airways when these structures are bypassed during anaesthesia and intensive care.

A prospective study to assess the safety and efficacy of Heat and Moisture Exchange filters and humidifiers in Mechanically Ventilated Patients. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/01/079199
Enrollment
90
Registered
2025-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: J98- Other respiratory disorders Health Condition 2: Z930- Tracheostomy status

Interventions

Intervention1: Heat and Moisture Exchange filters and humidifiers: Heat and Moisture Exchangers (HME) are intended to replace the normal warming and humidifying the upper airways of tracheal-intubated

Sponsors

Epsilon Medical Devices Sdn Bhd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1)Adults (â?¥18 years) requiring mechanical ventilation for â?¥24 hours. 2)Informed consent from the Legally Authorized Representative (LAR).

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1)Significant pre-existing lung disease.

Design outcomes

Primary

MeasureTime frame
Airway humidity levels as measured by digital psychrometry.Timepoint: The total duration of the study:3 months Time taken for each subject (if it involves interviews, follow up period):There is no follow-up involved in this study

Secondary

MeasureTime frame
1.Incidence of device-related adverse events. 2.Changes in ventilatory parameters, including peak airway pressures. 3.Occurrence of ventilator-associated pneumonia (VAP). Timepoint: The total duration of the study:3 months Time taken for each subject (if it involves interviews, follow up period):There is no follow-up involved in this study

Countries

India

Contacts

Public ContactDr Mathangi Krishnakumar

St Johnâ??s Medical College Hospital

mathangidoc@outlook.com919764062212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026