[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659365":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":33,"armGroups":29,"interventions":29,"overallOfficials":29,"centralContacts":29,"locations":34,"responsibleParty":56,"collaborators":29,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":29,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":29,"enrollmentInfo":67,"targetDuration":29,"studyType":70,"phases":29,"briefSummary":71,"conditions":72,"keywords":29,"overallStatus":76,"whyStopped":29,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Tameside General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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.","from enrollment to discharge or up to 30 days",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Critical care length of stay","Number of days occupying a critical care bed","from enrollment to discharge, or up to 30 days",{"measure":19,"description":20,"timeFrame":21},"Patient mobility","Time from tracheostomy insertion to first mobilisation out of bed, Mobilisation milestones","Time from tracheostomy insertion to first mobilisation out of bed, assessed up to 30 days",{"measure":23,"description":24,"timeFrame":25},"Reported quality of life","Staff and Patient Questionnaires completed on discharge from critical care","on discharge, or up to 30 days",{"measure":27,"description":28,"timeFrame":17},"Patient communication ability","Ability to communicate wants and needs, Clinical observations, Patient questionnaire response, Staff questionnaire response",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","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.",[35],{"facility":36,"status":29,"city":37,"state":29,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Tameside and Glossop Integrated Care NHS Foundation Trust","Ashton-under-Lyne","OL6 9RW","United Kingdom","UK",{"type":42,"coordinates":43},"Point",[44,45],-2.0989,53.48876,{"lat":45,"lon":44},[48,53],{"name":49,"role":50,"phone":51,"phoneExt":29,"email":52},"Rebecca Roberts","CONTACT","01619224451","rd@tgh.nhs.uk",{"name":54,"role":55,"phone":29,"phoneExt":29,"email":29},"Helen Evans","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100659365","trachphone-vs-warm-air-humidification-for-acute-trache-patients-on-icu-100659365",false,"NCT07862023","Trachphone vs Warm Air Humidification for Acute Trache Patients on ICU","An Observational Study to Understand the Impact of Trachphone for Patients With a Tracheostomy Verses Humidification Via Warm Air Circuit Ventilation","Inclusion Criteria:\n\n* Be aged 18 years or older\n* Have undergone acute tracheostomy\n* Be admitted to Critical Care\n* Be mechanically ventilated\n* Be clinically suitable for TrachPhone™\n* Provide informed consent or have consultee agreement obtained\n* Staff that have cared for an eligible participant will be invited to participate\n\nExclusion Criteria:\n\n* Are under 18 years of age\n* Have a clinical contraindication to TrachPhone™\n* Are receiving end-of-life care\n* Are considered unsuitable by the treating consultant","ALL","18 Years",{"count":68,"type":69},35,"ESTIMATED","OBSERVATIONAL","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.\n\nAlthough 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.\n\nThe 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.",[73,74,75],"Tracheostomy","Ventilated Patients","Critical Care","NOT_YET_RECRUITING","2026-10-01",{"date":79,"type":80},"2026-10-07","ACTUAL",{"date":82,"type":69},"2026-10",{"date":84,"type":69},"2027-08-31",{"name":5,"class":6},1]