Trials Sponsors Conditions Drugs Pricing

Conditions

Intensive Care Medicine Mechanical Ventilation Complication

Keywords

Mechanical VentilationMaximal Inspiratory Pressurehandgrip strengthPhysical function

Outcome Measures

Primary Outcomes (3)

Assessment of Inspiratory Pressure
Negative Inspiratory Force (NIF), also known as Maximal Inspiratory Pressure (MIP), is an indicator of respiratory muscle strength. To measure Negative Inspiratory Pressure, the expiratory hold button on the device will be pressed for 20 seconds. After this procedure, the patient will be instructed to take deep breaths voluntarily. In the resulting graph, the y-axis will display airway pressure (Paw). The most negative value on the y-axis, when added to the Positive End-Expiratory Pressure (PEEP) value, will determine and record the individuals maximal inspiratory value.
At baseline, on the day of enrollment
Assessment of physical function
The PFIT (Physical Function ICU Test) evaluates four key physical function components, each reported as a separate outcome measure. These components include standing ability, the level of assistance required for sit-to-stand, knee extension strength (assessed bilaterally), and the number of steps taken in one minute. MRC (Medical Research Council) muscle strength scale is used to determine knee flexion, elbow flexion and shoulder abduction muscle strength. Each parameter is scored between 0 and 3. A total score of 12 indicates that the person moves without support. These separate measures provide a comprehensive assessment of a patient's physical capacity in the ICU.Each parameter is scored between 0 and 3. A total score of 12 indicates that the person moves without support.
At baseline, on the day of enrollment

Study Arms (1)

HG and NIF

The cohort will consist of cooperative mechanically ventilated (MV) patients. In this patient group, the relationships between negative inspiratory force (NIF), handgrip strength (HG), and physical functional status will be examined.

Other: HG and NIF

Interventions

HG and NIFOther

In mechanically ventilated patients, handgrip strength, the Negative Inspiratory Force (NIF) value obtained via the ventilator, and physical function through various tests will be assessed.

HG and NIF

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Conscious and cooperative patients receiving mechanical ventilation (MV) support

You may qualify if:

Hemodynamically stable

Sponsors & Collaborators

SB Goztepe Prof Suleyman Yalcin City Hospital
Type not reportedcollaborator
Saglik Bilimleri Universitesi
Otherlead

Study Sites (1)

University of Health Sciences

Istanbul, 34353, Turkey (Türkiye)

Study Officials

Ahmet Aytekin, ICU Consultant
Goztepe Prof Dr Suleyman Yalcın City Hospital
STUDY CHAIR
Esra Pehlivan, Ass. Prof.
Saglik Bilimleri Universitesi
STUDY DIRECTOR
Mehmet Burak Uyaroglu, PhD(c). PT
Saglik Bilimleri Universitesi
PRINCIPAL INVESTIGATOR
Nezihe Ciftaslan Goksenoglu, ICU Consultant
Goztepe Prof Dr Suleyman Yalcın City Hospital
STUDY CHAIR

Enrollment

47 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

September 19, 2024

Actual (reported)

Maximum Inspiratory Pressure, Grip Strength and Physical Functional Status Relationship in MV Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

HG and NIF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

HG and NIF

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations