Quality of life in patients undergoing tracheostomy
| ISRCTN | ISRCTN24668317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24668317 |
- Submission date
- 23/04/2019
- Registration date
- 02/05/2019
- Last edited
- 09/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
Tracheostomy is a commonly performed procedure and is intended to provide a long-term surgical airway for patients who are dependent on mechanical ventilation. Due to its invasive and physiologically critical nature, tracheostomy can be associated with morbidity and have significant effects on patients’ quality of life. The aim of this study is to assess the quality of life of patients undergoing an elective tracheostomy in Intensive Care Units (ICU), revealing late tracheostomy-related complications and conditions for further improving health.
Who can participate?
Patients who were on mechanical ventilation in the ICU and underwent elective tracheostomy, who had the tracheostomy tube removed more than four months ago
What does the study involve?
Participants’ quality of life is assessed using questionnaires. A CT scan and spirometry (breathing) test are performed if needed.
What are the possible benefits and risks of participating?
The benefits of participating are measuring disease impact and assessing quality of life in people undergoing tracheostomy, finding out late tracheostomy-related complications for improving quality of life. A neck CT scan is a convenient and noninvasive way of evaluating problems in the neck. The scan takes little time and is painless. No radiation remains in a patient's body after a CT scan. The x-rays used in standard CT scans have no immediate side effects. There is always a slight chance of cancer from excessive exposure to radiation. However, the benefit of an accurate diagnosis will generally outweigh the risk. The effective radiation dose for this procedure varies. Women should always inform staff if there is any possibility that they are pregnant. CT scanning is, in general, not recommended for pregnant women unless medically necessary because of the potential risk to the baby. Generally, a spirometry procedure is very safe. Some patients report brief shortness of breath or dizziness after the test has been performed, but these will go away after a moment or two. Patients who have recently suffered from a heart attack or any heart-related condition are not ideal candidates for spirometry because the test requires some effort on the patient’s part. In very rare cases, spirometry is known to trigger breathing problems in patients.
Where is the study run from?
Yerevan State Medical University (Armenia)
When is the study starting and how long is it expected to run for?
May 2019 to December 2019
Who is funding the study?
Asmida Ltd
Who is the main contact?
Prof. Anna Poghosyan
anna.yu.poghosyan@gmail.com
Contact information
Scientific
25/14 Nalbandyan str., apt.100
Yerevan
0001
Armenia
 ORCID ID |
0000-0002-5116-5644 |
|---|---|
| Phone | +374 (0)91474169 |
| anna.yu.poghosyan@gmail.com |
Public
32/4 Moldovakan str. apt.6
Yerevan
0062
Armenia
| Phone | +374 (0)55 103055 |
|---|---|
| mashmedic77@gmail.com |
Public
4/3 Nar-Dos str. apt.5
Yerevan
0018
Armenia
| ORCID ID |
0000-0003-0860-1305 |
|---|---|
| Phone | +374 (0)93838588 |
| silva.avetisyan.95@gmail.com |
Scientific
4 Eznik Koghbaci str. apt.31
Yerevan
0001
Armenia
| ORCID ID |
0000-0001-6157-6714 |
|---|---|
| Phone | +374 (0)91456275 |
| imalkhas@mail.ru |
Scientific
2 Koryun str.
Yerevan
0025
Armenia
| ORCID ID |
0000-0002-6241-4159 |
|---|---|
| Phone | +374 (0)91415491 |
| proclinics@ysmu.am |
Scientific
10 Kievyan str. apt.10
Yerevan
0033
Armenia
| ORCID ID |
0000-0002-8436-2839 |
|---|---|
| Phone | +374 (0)93221929 |
| dr.shahparonyan@mail.ru |
Scientific
18 Vardanants str.
Yerevan
0010
Armenia
| ORCID ID |
0000-0001-7100-5106 |
|---|---|
| Phone | +374 (0)91405651 |
| info@vardanants.am |
Scientific
60 Abovyan str.
Yerevan
0025
Armenia
| ORCID ID |
0000-0001-8627-5942 |
|---|---|
| Phone | +374 (0)91408339 |
| heratsi.university.hospital@gmail.com |
Study information
| Study design | Observational retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Quality of life and late complications in patients undergoing tracheostomy in the ICU |
| Study acronym | QOL after tracheostomy |
| Study hypothesis | The study is taking place for assessment of QOL and revealing late complications in patients who underwent tracheostomy. The SRI questionnaire can reliably measure QOL in mechanically ventilated ICU patients who underwent tracheostomy. It may provide clinicians with an accurate assessment of patients’ quality of life. |
| Ethics approval(s) | Approved 21/02/2019, YSMU Ethics Board (2 Koryun str. Yerevan, Armenia 0025; Tel: +374 (0)60 621-307, 3-07; Email: ec@ysmu.am), ref: YSMU №7/18-19 |
| Condition | Condition after mechanical ventilation and tracheostomy performed in the ICU |
| Intervention | 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 spirometry are performed). |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/05/2019 |
| Overall study end date | 15/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 156 |
| Participant inclusion criteria | Patients who underwent tracheostomy in Intensive Care Units (ICU) on mechanical ventilation |
| Participant 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 |
| Recruitment start date | 15/05/2019 |
| Recruitment end date | 15/01/2020 |
Locations
Countries of recruitment
- Armenia
Study participating centre
Yerevan
0025
Armenia
Sponsor information
Hospital/treatment centre
60 Abovyan str.
Yerevan
0001
Armenia
| Phone | +374 (0)91474169 |
|---|---|
| anna.yu.poghosyan@gmail.com | |
| Website | hcplasticsurgery.com |
"ROR" |
https://ror.org/01vkzj587 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 15/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The publication of trial results is planned in December 2019. The researchers will publish the data regarding the main late complications of tracheostomy affecting patients' quality of life. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Anna Poghosyan (anna.yu.poghosyan@gmail.com). Final data regarding QoL assessment results will be available from 01/12/2019. Intermediate data regarding any tools and trial data could be requested any time from 01/06/2019 by email. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | non-peer-reviewed results in preprint | 20/08/2020 | 06/04/2021 | No | No |
| Results article | 07/07/2022 | 18/08/2022 | Yes | No | |
| Statistical Analysis Plan | version 0.3 | 22/08/2022 | No | No |
Additional files
Editorial Notes
09/01/2023: Internal review.
22/08/2022: Statistical analysis plan uploaded.
18/08/2022: Publication reference added.
06/04/2021: Preprint reference added.
27/01/2020: The final enrolment number has been added.
12/11/2019: The following changes have been made:
1. The recruitment end date has been changed from 07/10/2019 to 15/01/2020.
2. The overall trial end date has been changed from 01/12/2019 to 15/03/2020.
3. The intention to publish date has been changed from 05/12/2019 to 15/03/2021.
25/04/2019: Trial's existence confirmed by Yerevan State Medical University.
