Evaluation of Pulmonary Function in Burn Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Other: Respiratory function

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.

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Ozden Ozkal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength
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; Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 minutes
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	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.	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.	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.	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	15 minutes
Peripheral strength	Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles	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.	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.	10 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University
• Collaborators: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Ozden Ozkal, Hacettepe University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 29, 2019

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Burn Injury; Pulmonary function; Respiratory muscle; Peripheral muscle
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: GO 18/1110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No