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Evaluation of Pulmonary Function in Burn Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780218
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Ankara City Hospital Bilkent
Information provided by (Responsible Party):
Ozden Ozkal, Hacettepe University

Study Description
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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.

Condition or disease Intervention/treatment
Burns 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 Design
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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Pulmonary Function and Respiratory Muscle Strength in Patients With Burn Injury.
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Peak Expiratory Flow [ Time Frame: 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.

  2. forced expiratory flow [ Time Frame: 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.

  3. Peripheral strength [ Time Frame: 15 minutes ]
    Peripheral (Grip) strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles

  4. Pain severity [ Time Frame: 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.

  5. Functional Exercise Capacity [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Experimental group: Patients with burn injury Control Group: Healthy subjects
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780218


Locations
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Turkey
Ozden Ozkal
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Ankara City Hospital Bilkent
Investigators
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Principal Investigator: Ozden Ozkal Hacettepe University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ozden Ozkal, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03780218    
Other Study ID Numbers: GO 18/1110
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozden Ozkal, Hacettepe University:
Burn Injury
Pulmonary function
Respiratory muscle
Peripheral muscle
Additional relevant MeSH terms:
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Burns
Wounds and Injuries