- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04665024
Effect of Preoperative Chest Physiotherapy on Lung Functions Among Open Heart Surgery Patients
The Effect of Preoperative Chest Physiotherapy on Oxygenation and Lung Functions Among Open Heart Surgery Patients
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
The research was lasted four months in outpatient clinic, cardiothoracic surgical department and intensive care unit at University of Pécs, Clinical Centre, Heart Institute, Hungary . A convenient sample of 100 patients were divided into two groups: group 1 and 2. Group 1 (G1) included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation, and group 2 (G2) included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home. Preoperative and postoperative chest physiotherapy was performed in G1, and only postoperative one made in G2. Potential effects of preoperative chest physiotherapy were studied in both groups with respect to oxygen saturation, pulmonary complications and length of hospital staying. O2 saturation,O2 supplementation, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) were all measured in a day before (zero day) surgery as well as the first seven days of postoperative period.
Results: Measures of oxygen level and lung functions were significantly (P<0.05) changed in studied groups. The mean values of O2 saturation and supplementation measured in almost seven days of postoperative period were significantly (p<0.05) higher among G1 compared to the values of G2. The same trend was also correct for the mean values of FVC and FEV1.
Conclusions: The results concluded that, the performance of preoperative chest physiotherapy before open heart surgery is recommended, as it might result in the decrease of complications of heart surgery, improvement of respiratory functions and length of staying at hospital.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Pecs
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Pécs, Pecs, Węgry, H-7621
- Heart Institute,Medical School, University of Pécs
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
-
Exclusion Criteria:
- Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: Group 1
G1 included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation pre and postoperative chest physiotherapy was performed in G1. The chest physiotherapy included the following steps
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The patients were approached to partake in the investigation after they got full clarifications about the point of study. They were allocated into two groups and reassurance was achieved about the absence of any side effects.Furthermore, the examination was approved by the ethical committee. Effects of preoperative chest physiotherapy were compared between two groups, by measuring the lung functions, oxygen saturation, pulmonary complications and length of hospital staying. Lung functions were completed by utilizing spirometry parameters, oxygen saturation was measured by pulse oximeter and pulmonary complications were diagnosed by specialist doctors.
Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days.
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Aktywny komparator: Group 2
G2 included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home.only postoperative chest physiotherapy made in G2. The patient was seen on the first day after surgery in the intensive care unit and was asked if he had performed breathing exercises at home before surgery and then re-evaluation of both groups with respect to respiratory functions and oxygen saturation values from the first day until the seventh after surgery. Also, a daily chest physical therapy program was introduced in accordance with the hospital's policy until the patient's discharge. Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy mentioned above but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days. The exercises were repeated 10 times and performed 3-4 times per day. |
Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in oxygen saturation
Ramy czasowe: in a day before (zero day) surgery as well as the first seven days of postoperative period.
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Sao2
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in a day before (zero day) surgery as well as the first seven days of postoperative period.
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Change in pulmonary functions
Ramy czasowe: At the first seven days of postoperative period
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FVC and FEV1
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At the first seven days of postoperative period
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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pulmonary complications
Ramy czasowe: At the first seven days of postoperative period.
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pneumonia, atelectasis, phrenic nerve stimulation, ventilator
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At the first seven days of postoperative period.
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length of hospital staying
Ramy czasowe: The minimum stay for the patient is 7 days
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How many days did the patient stay in the hospital?
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The minimum stay for the patient is 7 days
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: VERZAR 7- ZSOFIA, Doctor, University of Pecs
Publikacje i pomocne linki
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
- 4114.316-474/kk15/2011
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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