Intensive Care Patients Invasively VentilatedNCT06609564
Inspiratory Muscle Training in Mechanically Ventilated Patients in Intensive Care Unit
A study testing inspiratory muscle training and Convantional chest physiotherapy in people with Intensive Care Patients Invasively Ventilated and Mechanical Ventilation, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
In addition to conventional chest physiotherapy, inspiratory muscle training will be applied in mechanically ventilated intensive care patients. It is aimed to examine the effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness, and diaphragm excursion in intubated or tracheostomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients Invasively Ventilated, Mechanical Ventilation, Inspiratory Muscle Training
- What is being tested?
- inspiratory muscle training and Convantional chest physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 2 Feb 2020
- Phase
- Interventional
- 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
Who may be able to join
- ≥18 years of age
- hemodynamic stability and alert
- able to spontaneously trigger the ventilator and perform at least one command for activation of respiratory muscles
- required mechanical ventilation support with continuous spontaneous ventilation mode or pressure- or volume-controlled intermittent mandatory ventilation (6 breaths/min) mode
- required pressure support ≤ 15 cmH2O and PEEP ≤ 10 cmH2O
- unable to breathe without support for 72 consecutive hours following the resolution of factors leading to respiratory failure
- FiO2 of 0.5 or less
- PaO2 greater than 60 mmHg and capable of sufficient gas exchange
Who cannot join
- cooperation disorder
- trauma or deformity related to the thorax that affect respiration
- progressive neuromuscular disease
- excessive bronchial secretion (requiring more than one suctioning per hour)
- need for continued sedative or analgesic agents
- use of home-type mechanical ventilation before admission to the hospital
- cardiac, pulmonary, or other conditions leading to impaired stability
- impaired cooperation, compliance, and motivation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inspiratory Muscle Training on Respiratory Muscle Strength, Diaphragm Thickness, and Diaphragm Excursion in Mechanically Ventilated Intensive Care Patients
In addition to conventional chest physiotherapy, inspiratory muscle training will be applied in mechanically ventilated intensive care patients. It is aimed to examine the effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness, and diaphragm excursion in intubated or tracheostomized patients with mechanical ventilation in the intensive care unit.
Read the detailed description
Subjects who mechanically ventilated in the intensive care unit will be divided two groups. Study group will recieve inspiratory muscle training in addition to convantional chest physiotherapy. Control group will recieve convantional chest physiotherapy. Training will continue until discharge or until the 21st day of the training. Respiratory muscle strength, diaphragm thickness and diaphragm excursion were measured before training and before discharge.
- Conditions
- Intensive Care Patients Invasively Ventilated, Mechanical Ventilation, Inspiratory Muscle Training, Diaphragm Ultrasonography
- Being tested
- inspiratory muscle training, Convantional chest physiotherapy
- Keywords
- Physiotherapy and Rehabilitation, Inspiratory Muscle Training, Ultrasound of Diaphragm, Intensive Care Unit, Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingDevice
Inspiratory muscle training with a pressure-adjustable device
Convantional chest physiotherapyOther
Chest physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Inspiratory muscle training in addition to convantional chest physiotherapy Receives: Device: inspiratory muscle training |
| Convational Chest Physiotherapy | Experimental | Diaphragm breathing, costal expansion exercises, postural drainage, effective coughing, in-bed range of motion exercises, and mobilization Receives: Other: Convantional chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strengh
Respiratory muscle strength was measured as maximal inspiratory pressure.
Measured: 20 minutes
Diaphragm thickness
Diaphragm thickness was evaluated using ultrasound imaging in two-dimensional B mode (4-13 MHz) performed from the midaxillary level from the right intercostal space with patients sitting in a position as upright as possible. The thickness of the diaphragm was ensured with the superficial probe at end-inspiration (Tins) and end-expiration (Texp).
Measured: 15 minutes
Diaphragm excursion
Diaphragm excursion was evaluated at the midaxillary level from the right subcostal area with M-mode (2-5 MHz) ultrasonography in normal inspiration and deep inspiration.
Measured: 20
Secondary outcomes (4)
Physical Function in Intensive Care Test (PFIT)
The PFIT is a test battery applied by the researchers that consists of four main headings: "Support (from sitting to standing up)," "Cadence (steps/minute)," "Shoulder (flexion strength)," and "Knee (extension strength)." Stand up from sitting was scored according to the degree of help received (0 = without help, 1 = with the help of one person, 2 = with the help of two people). We recorded standstill as the number of steps and the time elapsed while the standing still action was performed. Shoulder and knee muscle strength were assessed using a manual muscle test (0 = no contraction, 1 = contraction only, 2 = movement completed when gravity is eliminated, 3 = movement completed against gravity, 4 = movement completed with less than maximum resistance to gravity, 5 = movement completed with maximum resistance to gravity)
Measured: 20 minutes
Duration of intubation
After the subjects were included in the study duration of intubation was recorded.
Measured: 3-15 days
Extubation rate
Weaning rates of patients from mechanical ventilation
Measured: 3-15 days
Rate of discharge from the intensive care unit
Discharge rate of patients included in the study from intensive care unit
Measured: 8-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Sep 2017
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Patients Invasively VentilatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Harun Taşkın, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609564
- Sponsor's protocol ID
- 60116787-020/55139
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Respiratory Muscle Strength, Diaphragm Thickness, and Diaphragm Excursion in Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06609564
- Acronym / sponsor ID
- 60116787-020/55139
- Conditions
- Intensive Care Patients Invasively Ventilated, Mechanical Ventilation, Inspiratory Muscle Training, Diaphragm Ultrasonography
- Keywords
- Physiotherapy and Rehabilitation, Inspiratory Muscle Training, Ultrasound of Diaphragm, Intensive Care Unit, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 24 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.
In addition to conventional chest physiotherapy, inspiratory muscle training will be applied in mechanically ventilated intensive care patients. It is aimed to examine the effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness, and diaphragm excursion in intubated or tracheostomized patients with mechanical ventilation in the intensive care unit.
Detailed description
Subjects who mechanically ventilated in the intensive care unit will be divided two groups. Study group will recieve inspiratory muscle training in addition to convantional chest physiotherapy. Control group will recieve convantional chest physiotherapy. Training will continue until discharge or until the 21st day of the training. Respiratory muscle strength, diaphragm thickness and diaphragm excursion were measured before training and before discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Device: inspiratory muscle trainingInspiratory muscle training in addition to convantional chest physiotherapy |
| Convational Chest Physiotherapy | Experimental | Other: Convantional chest physiotherapyDiaphragm breathing, costal expansion exercises, postural drainage, effective coughing, in-bed range of motion exercises, and mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age
- hemodynamic stability and alert
- able to spontaneously trigger the ventilator and perform at least one command for activation of respiratory muscles
- required mechanical ventilation support with continuous spontaneous ventilation mode or pressure- or volume-controlled intermittent mandatory ventilation (6 breaths/min) mode
- required pressure support ≤ 15 cmH2O and PEEP ≤ 10 cmH2O
Key exclusion criteria (8 listed)
- cooperation disorder
- trauma or deformity related to the thorax that affect respiration
- progressive neuromuscular disease
- excessive bronchial secretion (requiring more than one suctioning per hour)
- need for continued sedative or analgesic 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 |
|---|---|---|
| inspiratory muscle trainingInspiratory muscle training with a pressure-adjustable device | Device | Inspiratory Muscle Training |
| Convantional chest physiotherapyChest physiotherapy | Other | Convational Chest Physiotherapy |
Primary outcome
Respiratory muscle strengh
Time frame: 20 minutes
Respiratory muscle strength was measured as maximal inspiratory pressure.
Diaphragm thickness
Time frame: 15 minutes
Diaphragm thickness was evaluated using ultrasound imaging in two-dimensional B mode (4-13 MHz) performed from the midaxillary level from the right intercostal space with patients sitting in a position as upright as possible. The thickness of the diaphragm was ensured with the superficial probe at end-inspiration (Tins) and end-expiration (Texp).
Diaphragm excursion
Time frame: 20
Diaphragm excursion was evaluated at the midaxillary level from the right subcostal area with M-mode (2-5 MHz) ultrasonography in normal inspiration and deep inspiration.
4 secondary outcomes
Physical Function in Intensive Care Test (PFIT)
Time frame: 20 minutes
Duration of intubation
Time frame: 3-15 days
Extubation rate
Time frame: 3-15 days
Rate of discharge from the intensive care unit
Time frame: 8-21 days
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 24 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training and Convantional chest physiotherapy in people with Intensive Care Patients Invasively Ventilated and Mechanical Ventilation, run by Afyonkarahisar Health Sciences University 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 8 inclusion and 8 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 24 Sep 2024. 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?
Respiratory muscle strengh (time frame: 20 minutes). 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 24 Sep 2024.