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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04272450
Other study ID # MIPMEP_Turkey
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 21, 2021
Est. completion date January 1, 2023

Study information

Verified date November 2022
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In determining respiratory muscle strength, mouth pressure measurement is most frequently used in the clinic. Determination of respiratory muscle strength loss provides benefits such as taking the decision to use individual rehabilitation methods, making the decision for extubation in patients with mechanical ventilation. But Turkey normative values, these values are not available. In the investigator's country, the respiratory muscle forces of the cases are evaluated by comparing them with the normal / expected values of the Scandinavian races that do not have similar anatomical features with the Turkish society, which causes errors in diagnosis. The 250 healthy cases, whose age ranges are between 20-70, 20-29, 30-40, 40-49, 50-59 and 60-70, will be examined by a pulmonologist and asked if they have any disease that may affect respiratory muscle strength. Mouth pressure measurements will be made for healthy and inclusion criteria, and maximal inspiratory and expiratory pressure distributions will be examined.


Recruitment information / eligibility

Status Completed
Enrollment 219
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - The age range is 20-70, - Body mass index to be 18.0- 29.5 kg / m2 - No cardiac, neuromuscular or endocrine disease that may affect any respiratory muscle strength Respiratory function parameters to be normal, - Not being a smoker Exclusion Criteria: - Not agreeing to participate in the study - Not being able to adapt to the device

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
respiratory muscle strenght measurement
Maximum inspiratory pressure-maximum expiratory pressure. The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated.

Locations

Country Name City State
Turkey University of Health Sciences Turkey Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory muscle strenght measurement Respiratory mus cle strength will be measured by measuring mouth pressure. Maximal inspiratory (MIP) and expiratory pressures (MEP) will be recorded. 30 minutes
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