BurnsNCT03780218

Evaluation of Pulmonary Function in Burn Injury

An observational study of Burns, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Burns
What is being tested?: Respiratory function
How many people: 94 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2019to 29 Oct 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ozden Ozkal
Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Pulmonary Function and Respiratory Muscle Strength in Patients With Burn Injury.

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.

Conditions: Burns
Being tested: Respiratory function
Keywords: Burn Injury, Pulmonary function, Respiratory muscle, Peripheral muscle
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03780218
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Respiratory function

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 15 minutes
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.
Measured: 15 minutes
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.
Measured: 15 minutes
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.
Measured: 15 minutes
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.
Measured: 15 minutes

Secondary outcomes (5)

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.
Measured: 15 minutes
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.
Measured: 15 minutes
Peripheral strength
Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Measured: 15 minutes
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.
Measured: 15 minutes
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.
Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201929 Oct 2019

First posted19 Dec 2018
Study start1 Jan 2019
Primary completion30 Sep 2019
Study completion29 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for BurnsStudies of the same condition, open and under way.
More trials run by Hacettepe UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03780218
Sponsor's protocol ID: GO 18/1110
Status last verified: Dec 2018
First submitted: 17 Dec 2018
Last updated: 1 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis

All Burns trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Pulmonary Function and Respiratory Muscle Strength in Patients With Burn Injury.
ClinicalTrials.gov ID: NCT03780218
Acronym / sponsor ID: GO 18/1110
Conditions: Burns
Keywords: Burn Injury, Pulmonary function, Respiratory muscle, Peripheral muscle
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Collaborators: Ankara City Hospital Bilkent
Study start: 1 Jan 2019 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 29 Oct 2019 (actual)
First posted: 19 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Experimental Group:Respiratory function	–	Other: Respiratory functionPatients 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.
Control Group:Respiratory function	–	Other: Respiratory functionHealthy 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Experimental group: Patients with burn injury Control Group: Healthy subjects

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Respiratory functionRespiratory function test evaluates the participants' pulmonary function and respiratory muscle strength	Other	Control Group:Respiratory function, Experimental Group:Respiratory function

Primary outcome

Forced Vital Capacity
Time frame: 15 minutes
is the total amount of air exhaled during the test. After three trial, the best forced vital capacity value is the outcome
Forced Expiratory Volume in 1 Second
Time frame: 15 minutes
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.
Forced Expiratory Volume in 1 Second / Forced Vital Capacity
Time frame: 15 minutes
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.
Maximal Inspiratory Pressure
Time frame: 15 minutes
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.
Maximal Expiratory Pressure
Time frame: 15 minutes
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.

5 secondary outcomes

Peak Expiratory Flow
Time frame: 15 minutes
forced expiratory flow
Time frame: 15 minutes
Peripheral strength
Time frame: 15 minutes
Pain severity
Time frame: 15 minutes
Functional Exercise Capacity
Time frame: 10 minutes

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Derived from this study: PubMed 31999499Ozkal 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.

Related trials for Burns

RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ozden Ozkal principal investigator

Hacettepe University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Burns, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Vital Capacity (time frame: 15 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03780218, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.