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Quality of life in patients undergoing tracheostomy

Quality of life and late complications in patients undergoing tracheostomy in the ICU

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN24668317
Enrollment
240
Registered
2019-05-02
Start date
2019-05-15
Completion date
Unknown
Last updated
2023-01-23

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

Conditions

Condition after mechanical ventilation and tracheostomy performed in the ICU Surgery

Interventions

Observation of QOL in persons who underwent tracheostomy by filling in the SRI questionnaire. In case of complaints, the cause of the complaints is examined (if needed a tracheal CT scan and spirometr

Sponsors

Yerevan State Medical University Heratsi Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who underwent tracheostomy in Intensive Care Units (ICU) on mechanical ventilation

Exclusion criteria

Exclusion criteria: 1. Does not want to participate in trial 2. Unable to participate due to general health reasons 3. Non tracheostomy related diseases of head and neck

Design outcomes

Primary

MeasureTime frame
1. Airway comfort measured using spirometry at baseline from the fourth month after decannulation 2. Dyspnea measured using the Medical Research Council (MRC) scale at baseline from the fourth month after decannulation 3. Wheezing and whistling while breathing measured using the acoustic value at baseline from the fourth month after decannulation 4. Pain measured using numerical rating scale (NRS) requires the patient to rate their pain on a defined scale from 0–10 where 0 is no pain and 10 is the worst pain imaginable, at baseline from the fourth month after decannulation 5. Scar comfort and scar aesthetic measured using Patient and Observer Scar Assessment Scale (POSAS) at baseline from the fourth month after decannulation 6. Neck mobility restriction measured using the range of back bend neck flexion at baseline from the fourth month after decannulation 7. Voice/speech disorders measured using Individual's Self Assessment of how voice problem affects emotions and self-image and ability to communicate effectively in everyday activities and in social and work settings at baseline from the fourth month after decannulation 8. Sleep disturbance measured using Subjective Assessment Measures by FOSQ-10 at baseline from the fourth month after decannulation 9. Swallowing disorders measured using a simple water swallowing test using standard 150 ml of water. Swallowing process assessed under three categories - swallowing speed (ml/s), swallowing volume (ml/swallow) and swallowing duration (s/swallow) at baseline from the fourth month after decannulation 10. Tracheostomy-related operations measured using anamnesis data: yes/no, if yes which kind of operation 11. Feeling of illness measured using standardized Acceptance of Illness Scale (AIS) at baseline from the fourth month after decannulation 12. Quality of life measured using the Severe Respiratory Insufficiency Questionnaire (SRI) at baseline from the fourth month after decannulation

Secondary

MeasureTime frame
1. Tracheal stenosis measured using CT scan, differentiated as mild, moderate and severe stenosis, at baseline from the fourth month after decannulation 2. Granulation tissue formation measured using clinical assessment at baseline from the fourth month after decannulation 3. Tracheocutaneous fistula measured using clinical assessment at baseline from the fourth month after decannulation 4. Tracheomalacia measured using CT scan at baseline from the fourth month after decannulation

Countries

Armenia

Contacts

Public ContactManush;Silva Hovhannisyan;Avetisyan

;

mashmedic77@gmail.com;silva.avetisyan.95@gmail.com+374 (0)55 103055;+374 (0)93838588

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 16, 2026