Condition category
Surgery
Date applied
23/04/2019
Date assigned
02/05/2019
Last edited
01/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anna Poghosyan

ORCID ID

http://orcid.org/0000-0002-5116-5644

Contact details

25/14 Nalbandyan str.
apt.100
Yerevan
0001
Armenia
+374 (0)91474169
anna.yu.poghosyan@gmail.com

Type

Public

Additional contact

Dr Manush Hovhannisyan

ORCID ID

Contact details

32/4 Moldovakan str. apt.6
Yerevan
0062
Armenia
+374 (0)55 103055
mashmedic77@gmail.com

Type

Public

Additional contact

Dr Silva Avetisyan

ORCID ID

http://orcid.org/0000-0003-0860-1305

Contact details

4/3 Nar-Dos str. apt.5
Yerevan
0018
Armenia
+374 (0)93838588
silva.avetisyan.95@gmail.com

Type

Scientific

Additional contact

Prof Irina Malkhasyan

ORCID ID

http://orcid.org/0000-0001-6157-6714

Contact details

4 Eznik Koghbaci str. apt.31
Yerevan
0001
Armenia
+374 (0)91456275
imalkhas@mail.ru

Type

Scientific

Additional contact

Prof Armen Minasyan

ORCID ID

http://orcid.org/0000-0002-6241-4159

Contact details

2 Koryun str.
Yerevan
0025
Armenia
+374 (0)91415491
proclinics@ysmu.am

Type

Scientific

Additional contact

Dr Rafik Shahparonyan

ORCID ID

http://orcid.org/0000-0002-8436-2839

Contact details

10 Kievyan str. apt.10
Yerevan
0033
Armenia
+374 (0)93221929
dr.shahparonyan@mail.ru

Type

Scientific

Additional contact

Prof Harutyun Mangoyan

ORCID ID

http://orcid.org/0000-0001-7100-5106

Contact details

18 Vardanants str.
Yerevan
0010
Armenia
+374 (0)91405651
info@vardanants.am

Type

Scientific

Additional contact

Prof Aren Bablumyan

ORCID ID

http://orcid.org/0000-0001-8627-5942

Contact details

60 Abovyan str.
Yerevan
0025
Armenia
+374 (0)91408339
heratsi.university.hospital@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

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

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

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

Study design

Observational retrospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

01/05/2019

Overall trial end date

01/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

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

07/10/2019

Locations

Countries of recruitment

Armenia

Trial participating centre

Yerevan State Medical University after Mkhitar Heratsi
2 Koryun str.
Yerevan
0025
Armenia

Sponsor information

Organisation

Yerevan State Medical University Heratsi Clinic

Sponsor details

60 Abovyan str.
Yerevan
0001
Armenia
+374 (0)91474169
anna.yu.poghosyan@gmail.com

Sponsor type

Hospital/treatment centre

Website

hcplasticsurgery.com

Funders

Funder type

Industry

Funder name

Asmida Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

05/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/04/2019: Trial's existence confirmed by Yerevan State Medical University.