NCT03780218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

November 1, 2019

Status Verified

December 1, 2018

Enrollment Period

9 months

First QC Date

December 17, 2018

Last Update Submit

October 30, 2019

Conditions

Burns

Keywords

Burn InjuryPulmonary functionRespiratory musclePeripheral muscle

Outcome Measures

Primary Outcomes (5)

  • 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 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 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 Outcomes (5)

  • Peak Expiratory Flow

    15 minutes

  • forced expiratory flow

    15 minutes

  • Peripheral strength

    15 minutes

  • Pain severity

    15 minutes

  • Functional Exercise Capacity

    10 minutes

Study Arms (2)

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

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

Interventions

Respiratory functionOTHER

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

Control Group:Respiratory functionExperimental Group:Respiratory function

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31999499DERIVED

MeSH Terms

Conditions

Burns

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Ozden Ozkal

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

January 1, 2019

Primary Completion

September 30, 2019

Study Completion

October 29, 2019

Last Updated

November 1, 2019

Record last verified: 2018-12

Locations

TU(1)