Evaluation of Pulmonary Function in Burn Injury

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780218
• Other study ID #: GO 18/1110
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: December 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: October 29, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
Turkey	Ozden Ozkal	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Peripheral strength	Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles	15 minutes
Secondary	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
Secondary	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