Mechanical Ventilation ComplicationNCT06602050
Maximum Inspiratory Pressure, Grip Strength and Physical Functional Status Relationship in MV Patients
An observational study of Mechanical Ventilation Complication and Intensive Care Medicine, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Intensive Care Medicine
- What is being tested?
- HG and NIF
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2024to 19 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Conscious and cooperative patients receiving mechanical ventilation (MV) support
Who may be able to join
- Hemodynamically stable
- Consciousness level sufficient to follow commands
- Patients with functionally intact extremities
Who cannot join
- Patients with neurological disorders (central or peripheral)
- Patients with craniocerebral injury
- Patients using medications that affect muscle tone
- Patients using sedative agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Relationship Between Maximum Inspiratory Pressure, Grip Strength and Physical Functional Status in Mechanically Ventilated Patients
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.
Read the detailed description
Progressive inadequate ventilation results in multiple organ dysfunction due to impaired oxygenation and subsequent hypoxia. Additionally, the combined effects of reduced exercise capacity and increased oxidative stress contribute to cardiovascular failure, further immobilization, increased peripheral muscle weakness, and a diminished quality of life. From this standpoint, there is a dynamic interaction between the respiratory muscles and peripheral striated muscles; strengthening one muscle group positively influences the other. Respiratory muscle strength is closely related to both limb muscle strength and endurance. Therefore, it is essential to assess not only respiratory but also peripheral muscle strength in mechanically ventilated patients.
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) are functional units used to assess respiratory muscle strength. In this context, various measurement methods developed to determine MIP and MEP provide valuable insights into the condition of patients\' respiratory muscles. Although invasive methods are sometimes used to evaluate respiratory muscle strength in mechanically ventilated patients, simple bedside measurements are often sufficient. One such method, particularly for ventilator-dependent patients, utilizes the negative inspiratory pressure value available through the ventilator\'s software features. In this procedure, the intensive care unit clinician instructs the patient to perform a strong inspiratory effort against a \"closed circuit\" within the system, and the resulting pressure serves as an indicator of inspiratory muscle strength. It is crucial that the patient is informed about the absence of airflow during this procedure and that they are cooperative.
Peripheral muscle strength is typically assessed using muscle strength tests or isokinetic evaluations. Additionally, grip strength measurement serves as a non-invasive indicator of both functional status and peripheral muscle strength in patients on mechanical ventilation .Respiratory muscles work in a complex interaction with peripheral muscles.This dynamic relationship has been described in many populations. In certain disease groups, peripheral muscle strength has been assessed through grip strength, while respiratory muscle strength was measured using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, allowing for the determination of the relationship between these two muscle groups. Typically, MIP is measured in the literature using manometers and specialized devices. However, this study was designed to measure MIP using the negative inspiratory pressure value-equivalent to maximal inspiratory pressure-directly from the mechanical ventilation device, without the use of external equipment and without disconnecting the patient from the respiratory circuit.The aim of this study is to determine the relationship between maximal inspiratory pressure, grip strength, and physical functional status in mechanically ventilated patients.
- Being tested
- HG and NIF
- Keywords
- Mechanical Ventilation, Maximal Inspiratory Pressure, handgrip strength, Physical function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HG and NIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline, on the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Sep 2024
- Primary completion19 Sep 2024
- Study completion19 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- SB Goztepe Prof Suleyman Yalcin City Hospital
- Responsible party
- Principal investigator, Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi
- Investigators
- Ahmet Aytekin, ICU Consultant, Study chair, Goztepe Prof Dr Suleyman Yalcın City HospitalEsra Pehlivan, Ass. Prof., Study director, Saglik Bilimleri UniversitesiMehmet Burak Uyaroglu, PhD(c). PT, Principal investigator, Saglik Bilimleri UniversitesiNezihe Ciftaslan Goksenoglu, ICU Consultant, Study chair, Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602050
- Sponsor's protocol ID
- sagbilimuni
- Status last verified
- May 2025
- First submitted
- 4 Sep 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Relationship Between Maximum Inspiratory Pressure, Grip Strength and Physical Functional Status in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06602050
- Acronym / sponsor ID
- sagbilimuni
- Keywords
- Mechanical Ventilation, Maximal Inspiratory Pressure, handgrip strength, Physical function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- SB Goztepe Prof Suleyman Yalcin City Hospital
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Progressive inadequate ventilation results in multiple organ dysfunction due to impaired oxygenation and subsequent hypoxia. Additionally, the combined effects of reduced exercise capacity and increased oxidative stress contribute to cardiovascular failure, further immobilization, increased peripheral muscle weakness, and a diminished quality of life. From this standpoint, there is a dynamic interaction between the respiratory muscles and peripheral striated muscles; strengthening one muscle group positively influences the other. Respiratory muscle strength is closely related to both limb muscle strength and endurance. Therefore, it is essential to assess not only respiratory but also peripheral muscle strength in mechanically ventilated patients.
Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) are functional units used to assess respiratory muscle strength. In this context, various measurement methods developed to determine MIP and MEP provide valuable insights into the condition of patients\' respiratory muscles. Although invasive methods are sometimes used to evaluate respiratory muscle strength in mechanically ventilated patients, simple bedside measurements are often sufficient. One such method, particularly for ventilator-dependent patients, utilizes the negative inspiratory pressure value available through the ventilator\'s software features. In this procedure, the intensive care unit clinician instructs the patient to perform a strong inspiratory effort against a \"closed circuit\" within the system, and the resulting pressure serves as an indicator of inspiratory muscle strength. It is crucial that the patient is informed about the absence of airflow during this procedure and that they are cooperative.
Peripheral muscle strength is typically assessed using muscle strength tests or isokinetic evaluations. Additionally, grip strength measurement serves as a non-invasive indicator of both functional status and peripheral muscle strength in patients on mechanical ventilation .Respiratory muscles work in a complex interaction with peripheral muscles.This dynamic relationship has been described in many populations. In certain disease groups, peripheral muscle strength has been assessed through grip strength, while respiratory muscle strength was measured using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, allowing for the determination of the relationship between these two muscle groups. Typically, MIP is measured in the literature using manometers and specialized devices. However, this study was designed to measure MIP using the negative inspiratory pressure value-equivalent to maximal inspiratory pressure-directly from the mechanical ventilation device, without the use of external equipment and without disconnecting the patient from the respiratory circuit.The aim of this study is to determine the relationship between maximal inspiratory pressure, grip strength, and physical functional status in mechanically ventilated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HG and NIF | – | Other: HG and NIFThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Conscious and cooperative patients receiving mechanical ventilation (MV) support
Key inclusion criteria (3 listed)
- Hemodynamically stable
- Consciousness level sufficient to follow commands
- Patients with functionally intact extremities
Key exclusion criteria (4 listed)
- Patients with neurological disorders (central or peripheral)
- Patients with craniocerebral injury
- Patients using medications that affect muscle tone
- Patients using sedative agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HG and NIFIn mechanically ventilated patients, handgrip strength, the Negative Inspiratory Force (NIF) value obtained via the ventilator, and physical function through various tests will be assessed. | Other | HG and NIF |
Primary outcome
Assessment of Inspiratory Pressure
Time frame: At baseline, on the day of enrollment
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.
Assessment of physical function
Time frame: At baseline, on the day of enrollment
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.
Assesment of Hand Grip Measurement
Time frame: At baseline, on the day of enrollment
Handgrip strength will be measured in pounds (lbs) using the Jamar Hydraulic Hand Dynamometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Aytekin, ICU Consultant study chair
Goztepe Prof Dr Suleyman Yalcın City Hospital
Esra Pehlivan, Ass. Prof. study director
Saglik Bilimleri Universitesi
Mehmet Burak Uyaroglu, PhD(c). PT principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Intensive Care Medicine, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Inspiratory Pressure (time frame: At baseline, on the day of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.