- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07571642
Respiratory Muscle Training in the ICU: IMT vs Diaphragmatic NMES
Comparing the Effects of Inspiratory Muscle Training and Diaphragmatic Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients: A Randomized Controlled Trial
Przegląd badań
Status
Warunki
Szczegółowy opis
This randomized study aimed to compare the effects of Inspiratory Muscle Training (IMT) and Neuromuscular Electrical Stimulation (NMES) on inspiratory muscle strength, mechanical ventilator parameters, and functional levels in intensive care unit (ICU) patients.
A total of 32 mechanically ventilated patients were randomly assigned to either an IMT group (n=16) or an NMES group (n=16). In addition to routine ICU physiotherapy, the IMT group received inspiratory muscle training using Philips Respironics Threshold IMT devices, while the NMES group received stimulation on the diaphragm with Aussie current using surface electrodes.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Hatay, Turcja (Türkiye), 31060
- Hatay Mustafa Kemal University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria
- Being intubated
- Conscious state
- Ability to trigger mechanical ventilation
- Capability to execute at least one motor command
Exclusion Criteria
- Any neurological or orthopedic diagnosis or deficits
- Inability to cooperate with the physiotherapist
- Hemodynamic instability despite medical treatment
- Excessive secretions requiring aspiration more than once per hour.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Inspiratory Muscle Training (IMT)
As a result of randomization, the IMT group consisted of 16 participants with a mean age of 70 ± 9.57 years.
IMT was administered to the participants twice a day following routine physiotherapy, which included breathing exercises and mobilization.
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Routine ICU physiotherapy includes: conventional chest physiotherapy, consisting of diaphragmatic breathing, thoracic expansion exercises, postural drainage, cough training, and in-bed ROM exercises and mobilization.
In addition to routine ICU physiotherapy, patients received IMT twice daily with Threshold IMT devices (Respironics, New Jersey, Inc., NJ, USA).
The IMT program started at 30% of pretreatment Pimax and was increased by 2H2O daily according to patients' tolerance.
A total of 3 sets of 8 repetitions were applied.
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Eksperymentalny: Neuromuscular electric stimulation (NMES)
As a result of randomization, the NMES group consisted of 16 participants with a mean age of 65.31 ± 8.38 years.
Following routine intensive care physiotherapy, which included breathing exercises and mobilization, NMES was applied to the diaphragm muscle for 40 minutes.
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Routine ICU physiotherapy includes: conventional chest physiotherapy, consisting of diaphragmatic breathing, thoracic expansion exercises, postural drainage, cough training, and in-bed ROM exercises and mobilization.
In addition to routine ICU physiotherapy, patients received NMES on the diaphragm with surface electrodes.
Electrodes were placed at four channels with two electrodes on both sides of the xiphoid at the level of the intercostal space of the 7th and 8th ribs, superiorly and inferiorly.
In addition, two electrodes with two channels were placed superiorly and inferiorly at the midaxillary level of the intercostal space of the 7th and 8th ribs.
A total of 4 channels and 8 electrodes were used with modified burst series biphasic current 30 Hz (Aussie current).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Inspiratory muscle strength
Ramy czasowe: Baseline, 1 hour before extubation, 1 hour before discharge
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Inspiratory muscle strength (Pimax) was assessed by a desktop spirometer with Pimax module (Pony Fx, COSMED, Rome, Italy).
A catheter mount piece was placed in front of the pressure measurement part of spirometer to perform the measurement in intubated participants.
Participants were encouraged throughout the measurements to achieve maximum strength and coordination.
The measurements were repeated three times, and the average of these values was recorded.
To prevent respiratory muscle fatigue, at least a one-minute break was provided between trials.
Results were reported in cmH2O units.
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Baseline, 1 hour before extubation, 1 hour before discharge
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Physical Functions
Ramy czasowe: Baseline, 1 hour before discharge
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Physical function levels of patients were evaluated by Physical Function Intensive Care Unit Test-scored (PFIT-s).
Physical Function Intensive Care Unit Test-scored has 4 test components; shoulder flexion strength, knee extension strength, sit to stand assistance, step cadence.
Before the test, the participant was expected to correctly answer 2 of 5 questions to assessing the cooperation.
Participants' vital signs were noted before and after the test.
Participants are scored on a total scale ranging from 0 to 10.
A score of 0 signifies total dependence and poor muscle strength, whereas a score of 10 represents functional independence and optimal muscle strength.
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Baseline, 1 hour before discharge
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Mechanical Ventilatory Parameters - Tidal Volumes
Ramy czasowe: Baseline, 1 hour before extubation
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Respitatory parameters were assessed by mechanic ventilator (The Engstrom Carestation, GE Health Care 2016).
The test procedure; device was switched to CPAP mode, Psupport was set to 10 cmH2O and PEEP was set to 5 cmH2O to overcome the physiological resistance of the ventilator circuit.
The patient was instructed to take deep breaths for one minute.
As the measurements required patient motivation and coordination, the tests were conducted by providing appropriate verbal commands.
Inspiratory tidal volume (TVi) and expiratory tidal volume (TVe) were recorded in milliliters (ml).
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Baseline, 1 hour before extubation
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Mechanical Ventilatory Parameter - Minute Ventilation
Ramy czasowe: Baseline, 1 hour before extubation
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Respitatory parameters were assessed by mechanic ventilator (The Engstrom Carestation, GE Health Care 2016).
The test procedure; device was switched to CPAP mode, Psupport was set to 10 cmH2O and PEEP was set to 5 cmH2O to overcome the physiological resistance of the ventilator circuit.The patient was instructed to perform deep breathing for a period of one minute.
Since the measurement required patient motivation and coordination, the tests were conducted by providing appropriate verbal commands.
Minute ventilation was recorded in liters per minute (L/min)
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Baseline, 1 hour before extubation
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Length of time intubated
Ramy czasowe: 12 hours after extubation
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The duration of intubation for the participants was reported in days.
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12 hours after extubation
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Hospital stay length
Ramy czasowe: 2 hours after discharge
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The duration of hospital stay was reported in days
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2 hours after discharge
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Denehy L, de Morton NA, Skinner EH, Edbrooke L, Haines K, Warrillow S, Berney S. A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther. 2013 Dec;93(12):1636-45. doi: 10.2522/ptj.20120310. Epub 2013 Jul 25.
- Leite MA, Osaku EF, Albert J, Costa CRLM, Garcia AM, Czapiesvski FDN, Ogasawara SM, Bertolini GRF, Jorge AC, Duarte PAD. Effects of Neuromuscular Electrical Stimulation of the Quadriceps and Diaphragm in Critically Ill Patients: A Pilot Study. Crit Care Res Pract. 2018 Jul 8;2018:4298583. doi: 10.1155/2018/4298583. eCollection 2018.
- Dos Santos FV, Cipriano G Jr, Vieira L, Guntzel Chiappa AM, Cipriano GBF, Vieira P, Zago JG, Castilhos M, da Silva ML, Chiappa GR. Neuromuscular electrical stimulation combined with exercise decreases duration of mechanical ventilation in ICU patients: A randomized controlled trial. Physiother Theory Pract. 2020 May;36(5):580-588. doi: 10.1080/09593985.2018.1490363. Epub 2018 Oct 15.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 60116787-020/46004
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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