Evaluation of Pulmonary Function in Burn Injury

Completed

• Conditions: Burns
• Interventions: Other: Respiratory function

• Registration Number: NCT03780218
• Lead Sponsor: Hacettepe University

Brief 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.

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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study First Posted: 2018-12-19
• Study Start: 2019-01-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-29
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental Group:Respiratory function	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.
Control Group:Respiratory function	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
forced expiratory flow	15 minutes	Forced expiratory flow is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.
Functional Exercise Capacity	10 minutes	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.
Peak Expiratory Flow	15 minutes	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.
Peripheral strength	15 minutes	Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Pain severity	15 minutes	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.

Trial Locations

Locations (1)

Ozden Ozkal; 🇹🇷 Ankara, Turkey