Skip to content

A study of the clinical application of heat and humidity exchangers

A study of the effectiveness of heat and humidity exchangers in post-total laryngectomy patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100922
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-01-07
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Laryngeal cancer

Interventions

Experimental group:Neck stoma care with heat and moisture exchanger + neck stoma sump.
Control group:Existing neck stoma care modalities

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients after total laryngectomy; 2.Age greater than 18 years and less than 75 years;any gender; 3.No laryngeal reconstruction surgery; 4.>=3 months from total laryngectomy; 5.>= 6 weeks from last radiotherapy and no radiotherapy is expected during the study period; 6.Able to cooperate with follow-up visits; 7.Fully understand the risks and benefits of this study, participate in the trial voluntarily, and have the informed consent form signed by themselves or their legal guardians.

Exclusion criteria

Exclusion criteria: 1.Heat and moisture exchanger used within the last 3 months; 2.Presence of contraindications to the use of heat and moisture exchangers (e.g. presence of severe skin lesions at the stoma, etc.); 3.Patients with locally recurrent or metastatic tumors; 4.Low tidal volume; 5.Recent lung infection/unstable lung condition; 6.Stoma stenosis requiring trocars; 7.Daily users of pneumatic artificial larynx; 8.Individuals with inadequate physical, cognitive, or mental abilities required to install, remove, or operate the equipment itself (e.g., Parkinson's, etc. resulting in impaired fine motor function, etc.); 9.Those whom the researchers believe are not suitable for clinical trials for other reasons.

Design outcomes

Primary

MeasureTime frame
Cough and sputum assessment;

Secondary

MeasureTime frame
EQ-5D-5L;Borg's subjective level of fatigue;Jenkins;SAE;

Countries

China

Contacts

Public ContactHaoqing Su

Peking Union Medical College Hospital

pumch_sue@sina.com+86 10 69152721

Outcome results

None listed

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