- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Pecs
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Pécs, Pecs, Maďarsko, H-7621
- Heart Institute,Medical School, University of Pécs
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
-
Exclusion Criteria:
- Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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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Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in oxygen saturation
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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pulmonary complications
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: VERZAR 7- ZSOFIA, Doctor, University of Pecs
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 4114.316-474/kk15/2011
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