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

NCT06602050 | Completed

• 1 other identifier: sagbilimuni
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The maximal inspiratory pressure or negative inspiratory force values is a parameter that measures the functional ability of the respiratory system. The ability to reduce the risk of atelectasis, effective coughing and mobilization of airway secretions is directly proportional to the magnitude of this value. Grip strength is a parameter that noninvasively assesses functional status in critical care patients.Respiratory muscles work in a complex interaction with peripheral muscles. This dynamic relationship has been described in many populations.The aim of this study was to determine the relationship between maximum inspiratory pressure and grip strength and physical functional status in mechanical ventilator patients.

Conditions

Mechanical Ventilation Complication; Intensive Care Medicine

Keywords

Mechanical Ventilation; Maximal Inspiratory Pressure; handgrip strength; Physical 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

• Assesment of Hand Grip Measurement

  Handgrip strength will be measured in pounds (lbs) using the Jamar Hydraulic Hand Dynamometer.

  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 NIF OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Conscious and cooperative patients receiving mechanical ventilation (MV) support

You may qualify if:

• Hemodynamically stable
• Consciousness level sufficient to follow commands
• Patients with functionally intact extremities

You may not qualify if:

• Patients with neurological disorders (central or peripheral)
• Patients with craniocerebral injury
• Patients using medications that affect muscle tone
• Patients using sedative agents

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead
• SB Goztepe Prof Suleyman Yalcin City Hospital: collaborator

Study Sites (1)

University of Health Sciences

Istanbul, 34353, Turkey (Türkiye)

Location

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

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
• Primary Completion: September 19, 2024
• Study Completion: April 19, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

TU (1)