Trachphone vs Warm Air Humidification for Acute Trache Patients on ICU
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTameside General Hospital
About this trial
A tracheostomy is a surgical opening made in the windpipe (trachea) through the neck to help a person breathe. A tube is placed in the opening to keep it open. As a result, the air reaching the lungs can be cooler, drier and less well filtered. This can lead to thicker mucus, coughing, difficulty clearing secretions, and an increased risk of chest infections or breathing problems caused by mucus blockages. To help replace some of the moisture normally provided by the nose and throat, humidification is often used. Different methods of humidification are used in clinical practice, although approaches may vary between healthcare centres.
Although Heat and Moisture Exchangers (HMEs) have been available for many years for people with a tracheostomy who breathe independently, their use remains limited and varies across healthcare settings. Existing research suggests that HMEs are generally well tolerated and may help keep airway secretions thinner and easier to clear, however the evidence available is limited and further research is needed for a better understanding of the clinical benefits and limitations.
The purpose of this study is to compare two humidification methods used for tracheostomy patients receiving ventilator support in critical care: the TrachPhone, a single use Heat and Moisture Exchanger (HME) device and warm air ventilation humidification. The investigators want to understand whether either method offers advantages in secretion management, patient safety, comfort, and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be aged 18 years or older
Have undergone acute tracheostomy
Be admitted to Critical Care
Be mechanically ventilated
Disqualifiers
Are under 18 years of age
Have a clinical contraindication to TrachPhone™
Are receiving end-of-life care
Are considered unsuitable by the treating consultant
Trial population
The investigators are inviting patients aged 18 years or older, who have been admitted to the critical care unit at Tameside Hospital and have undergone a tracheostomy, to participate in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
feasibility and tolerability of TrachPhone
The primary outcome measure will be the feasibility and tolerability of TrachPhone™ when used as intended by both patients and staff. This will be a non-validated questionnaire using a satisfaction scale, ranging from very easy to very difficult, strongly agree to strongly disagree etc.
Time frame
from enrollment to discharge or up to 30 daysSecondary outcomes
1
Critical care length of stay
Number of days occupying a critical care bed
Time frame
from enrollment to discharge, or up to 30 days2
Patient mobility
Time from tracheostomy insertion to first mobilisation out of bed, Mobilisation milestones
Time frame
Time from tracheostomy insertion to first mobilisation out of bed, assessed up to 30 days3
Reported quality of life
Staff and Patient Questionnaires completed on discharge from critical care
Time frame
on discharge, or up to 30 days4
Patient communication ability
Ability to communicate wants and needs, Clinical observations, Patient questionnaire response, Staff questionnaire response
Time frame
from enrollment to discharge, or up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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