CClinicalTrials.gg
CompletedNCT03780218Updated Nov 1, 2019

Evaluation of Pulmonary Function in Burn Injury

An observational study in Burns, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
94
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study evaluates the pulmonary function, respiratory muscle strength and peripheral muscle strength in patients with burn injury on the week that they will be discharge from the hospital. Healthy subjects will be evaluated for pulmonary function, respiratory muscle strength and peripheral muscle strength.

Read the detailed description

Burn injures have adverse effect on the respiratory system.In addition to burn injury prolonged hospitalization may increase the ratio of respiratory complications. But, there are no information in the literature about pulmonary function, respiratory muscle strength and peripheral muscle strength in patients with burn injury. Especially, when the patients are discharged from the hospital, it is not known whether the patients are at the same level in terms of pulmonary functions respiratory muscle strength and peripheral muscle strength with healthy individuals. This study will assess pulmonary functions respiratory muscle strength and peripheral muscle strength in patients with burn injury compared to healthy subjects.

02

Conditions studied

  • Burns

Browse trials for

Keywords

  • Burn Injury
  • Pulmonary function
  • Respiratory muscle
  • Peripheral muscle
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 94 is above the median of 55 across 135 observational studies indexed under Burns.

Browse Burns studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Experimental group: Patients with burn injury Control Group: Healthy subjects

Inclusion criteria

  • Having a burn injury
  • Treatment by an inpatient
  • able and willing to complete the informed consent process.
  • Control group consists of healthy adults with the similar demographic characteristics as experimental group

Exclusion criteria

Exclusion Criteria:

  • having a pulmonary system disease
  • having a cardiac system disease
  • to do regular sports for the last three months
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
94 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental Group:Respiratory function

    Patients with burn injury will be included in this study. Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed on the discharge week.

    Other: Respiratory function

  • Control Group:Respiratory function

    Healthy subjects will be included in this study.Their respiratory functions will be evaluated. Pulmonary function test, respiratory muscle strength and peripheral muscle strength will be assessed.

    Other: Respiratory function

Interventions

  • OtherRespiratory function

    Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength

06

What researchers measure

Primary outcomes

  1. Forced Vital Capacity

    is the total amount of air exhaled during the test. After three trial, the best forced vital capacity value is the outcome

    Time frame: 15 minutes

  2. Forced Expiratory Volume in 1 Second

    Forced Expiratory Volume in 1 Second is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. After three trial, the best FVC value is the outcome.

    Time frame: 15 minutes

  3. Forced Expiratory Volume in 1 Second / Forced Vital Capacity

    The ratio of Forced Expiratory Volume in 1 Second / Forced Vital Capacity. This formule is calculated by measuring device. After three trial, the best value is the outcome.

    Time frame: 15 minutes

  4. Maximal Inspiratory Pressure

    is a measure of the strength of inspiratory muscles, primarily the diaphragm. It is obtained by having the patient inhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.

    Time frame: 15 minutes

  5. Maximal Expiratory Pressure

    a measure of the strength of respiratory muscles, obtained by having the patient exhale as strongly as possible against a mouthpiece. After three trial, the best value is the outcome.

    Time frame: 15 minutes

Secondary outcomes

  1. Peak Expiratory Flow

    Peak Expiratory Flow is a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. After three trial, the best value is the outcome.

    Time frame: 15 minutes

  2. forced expiratory flow

    Forced expiratory flow is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.

    Time frame: 15 minutes

  3. Peripheral strength

    Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles

    Time frame: 15 minutes

  4. Pain severity

    Pain severity was assessed by visual analogue scale. This scale score range from "no pain=0 point " to "worst imaginable pain=10 points" for intensity. Maximum point means worst pain severity.

    Time frame: 15 minutes

  5. Functional Exercise Capacity

    It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.

    Time frame: 10 minutes

07

Study locations

1 site
  • Ozden Ozkal
    Ankara, 06100, Turkey
08

References and documents

Publications

  • Ozkal O, Topuz S, Karahan S, Erdem MM, Konan A, Yasti AC. Clinical predictors of pulmonary functions, respiratory/peripheral muscle strength and exercise capacity at discharge in adults with burn injury. Disabil Rehabil. 2021 Oct;43(20):2875-2881. doi: 10.1080/09638288.2020.1720320. Epub 2020 Jan 30. PubMed 31999499 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03780218
Lead sponsor
Hacettepe University
Collaborators
Ankara City Hospital Bilkent
Responsible party
Ozden Ozkal (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Dec 19, 2018
Start date
Jan 1, 2019
Primary completion
Sep 30, 2019
Completion
Oct 29, 2019
Last update
Nov 1, 2019

Study contacts

Ozden Ozkal
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion