RecruitingPhase 2NCT05358262

High Heated Humidity in Stem Cell Transplant

Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant


Sponsor

AHS Cancer Control Alberta

Enrollment

90 participants

Start Date

Nov 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Minimum 18 years of age
  • Have given written consent prior to any study-specific procedures or have had an acceptable individual capable of giving consent on the patient's behalf.
  • Have one of non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma and found to require high-dose, melphalan-based chemotherapy and autologous stem cell transplant (ASCT) as part of standard of care treatment (includes patients receiving ASCT also requiring oxygen).
  • Performance status of ECOG 0-2
  • Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.

Exclusion Criteria5

  • Nasal blockage such as nasal polyps, deviated septum or nasal packing would either not allow the proper flow of heated humidity into the nares or it would be too uncomfortable to tolerate during the intervention.
  • Those with influenza like illness. The intervention is not in itself, an aerosol generating medical device. However, if influenza positive, there could be airborne spread of the virus impacting both staff and other patients.
  • Tracheostomy Tube Patients would require a different type of equipment attachment which is not included in this study. Tracheostomy tubes by-pass the upper airway and therefore the intervention cannot be used for the purpose of assessing mucositis. This intervention is used regularly on tracheostomy patients with good success however in this case, the upper airway is by-passed and therefore there would be no impact on mucositis.
  • Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician.
  • Patients who have Obstructive Sleep Apnea who use a CPAP machine at night. This population would not be able to use the intervention concurrently with the CPAP device as both utilize the nares.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAirvo

Fisher \& Paykel's AIRVO 2 is a humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of interfaces including nasal cannula. Flow can be delivered from 2 to 60 LPM

OTHERStandard of Care

The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.


Locations(1)

Cross Cancer Institute

Edmonton, Alberta, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05358262


Related Trials