Quality of life in patients undergoing tracheostomy

ISRCTN	ISRCTN24668317
DOI	https://doi.org/10.1186/ISRCTN24668317
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Yerevan State Medical University Heratsi Clinic
Funders	Asmida Ltd, Investigator initiated and funded

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Prof Anna Poghosyan
Scientific

25/14 Nalbandyan str., apt.100
Yerevan
0001
Armenia

ORCID ID	0000-0002-5116-5644
Phone	+374 (0)91474169
Email	anna.yu.poghosyan@gmail.com

Dr Manush Hovhannisyan
Public

32/4 Moldovakan str. apt.6
Yerevan
0062
Armenia

Phone	+374 (0)55 103055
Email	mashmedic77@gmail.com

Dr Silva Avetisyan
Public

4/3 Nar-Dos str. apt.5
Yerevan
0018
Armenia

ORCID ID	0000-0003-0860-1305
Phone	+374 (0)93838588
Email	silva.avetisyan.95@gmail.com

Prof Irina Malkhasyan
Scientific

4 Eznik Koghbaci str. apt.31
Yerevan
0001
Armenia

ORCID ID	0000-0001-6157-6714
Phone	+374 (0)91456275
Email	imalkhas@mail.ru

Prof Armen Minasyan
Scientific

2 Koryun str.
Yerevan
0025
Armenia

ORCID ID	0000-0002-6241-4159
Phone	+374 (0)91415491
Email	proclinics@ysmu.am

Dr Rafik Shahparonyan
Scientific

10 Kievyan str. apt.10
Yerevan
0033
Armenia

ORCID ID	0000-0002-8436-2839
Phone	+374 (0)93221929
Email	dr.shahparonyan@mail.ru

Prof Harutyun Mangoyan
Scientific

18 Vardanants str.
Yerevan
0010
Armenia

ORCID ID	0000-0001-7100-5106
Phone	+374 (0)91405651
Email	info@vardanants.am

Prof Aren Bablumyan
Scientific

60 Abovyan str.
Yerevan
0025
Armenia

ORCID ID	0000-0001-8627-5942
Phone	+374 (0)91408339
Email	heratsi.university.hospital@gmail.com

Study information

Primary study design	Observational
Study design	Observational retrospective cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Quality of life and late complications in patients undergoing tracheostomy in the ICU
Study acronym	QOL after tracheostomy
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	15/03/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	240
Total final enrolment	156
Key inclusion criteria	Patients who underwent tracheostomy in Intensive Care Units (ICU) on mechanical ventilation
Key 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
Date of first enrolment	15/05/2019
Date of final enrolment	15/01/2020

Locations

Countries of recruitment

Armenia

Study participating centre

Yerevan State Medical University after Mkhitar Heratsi

2 Koryun str.
Yerevan
0025
Armenia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
Results article		07/07/2022	18/08/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Preprint results	non-peer-reviewed results in preprint	20/08/2020	06/04/2021	No	No
Statistical Analysis Plan	version 0.3		22/08/2022	No	No

Additional files

ISRCTN24668317_SAP_V0.3.pdf: Statistical Analysis Plan

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.