NCT04272450

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

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

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 9, 2023

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

February 12, 2020

Last Update Submit

May 6, 2023

Conditions

Keywords

respiratory musclemouth pressurenormative datapredicted valuerespiratory muscle strenghtTurkeyIstanbul

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • 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

You may not qualify if:

  • Not agreeing to participate in the study
  • Not being able to adapt to the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Istanbul, 34668, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

October 21, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 9, 2023

Record last verified: 2022-11

Locations