- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07591987
Effect of Different Breathing Techniques on Dyspnea and Cardiopulmonary Parameters Among Patients After Open Heart Surgery
Effect of Segmental Breathing Versus Active Cycle Breathing Techniques on Dyspnea and Cardiopulmonary Parameters Among Patients After Open Heart Surgery: Randomized Controlled Trial.
Open heart surgery is often associated with postoperative pulmonary complications, reduced lung expansion, dyspnea, and impaired cardiopulmonary function. Breathing exercises are commonly used after surgery to improve lung ventilation, enhance oxygenation, and support respiratory recovery. However, limited evidence is available comparing the effectiveness of segmental breathing exercises and active cycle breathing technique (ACBT) in patients after open heart surgery.
This randomized controlled trial will compare the effects of segmental breathing exercises and ACBT on dyspnea and cardiopulmonary parameters in adults undergoing open heart surgery. Participants will be randomly assigned to either the segmental breathing exercise group, the ACBT group, or the standard care group during the postoperative period following extubation.
Cardiopulmonary parameters, including oxygen saturation, respiratory rate, heart rate, and blood pressure, as well as dyspnea severity and postoperative pulmonary complications, will be assessed before and after the interventions.
The findings of this study may help identify the most effective breathing exercise technique for improving respiratory outcomes, reducing postoperative pulmonary complications, and supporting evidence-based postoperative rehabilitation after cardiac surgery.
Przegląd badań
Status
Szczegółowy opis
This randomized clinical trial evaluates the effects of segmental breathing exercises (SBE) and active cycle breathing technique (ACBT) on dyspnea, cardiopulmonary parameters, and postoperative pulmonary complications in adults undergoing elective open-heart surgery with cardiopulmonary bypass.
Participants will be randomly assigned to one of three groups: segmental breathing exercises group, active cycle breathing technique group, or standard care group. Patients in the intervention groups will perform the assigned breathing exercises after extubation, including sessions conducted 1 hour and 6 hours post-intervention during the early postoperative period.
Cardiopulmonary parameters, including oxygen saturation, respiratory rate, heart rate, and blood pressure parameters, will be monitored throughout hospitalization. Dyspnea and postoperative pulmonary complications, including atelectasis and pneumonia, will also be assessed.
The primary purpose of this study is to determine the effectiveness of breathing exercise interventions in improving postoperative respiratory outcomes and reducing pulmonary complications after cardiac surgery. The study also aims to support evidence-based postoperative rehabilitation practices for healthcare professionals caring for patients after open-heart surgery.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Muslim Aqeel Essa, Master Student
- Numer telefonu: +9647822218483
- E-mail: muslim.eesa2402m@conursing.uobaghdad.edu.iq
Kopia zapasowa kontaktu do badania
- Nazwa: Rusul Khalid Kadhim, Master Student
Lokalizacje studiów
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Irak, 10001
- Rekrutacyjny
- Ibn Al-Bitar Specialized Hospital for Cardiac Surgery
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Główny śledczy:
- Muslim Aqeel Essa, Master student
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Baghdad, Baghdad Governorate, Irak, 10001
- Rekrutacyjny
- Iraqi Center for Heart Diseases
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Główny śledczy:
- Muslim Aqeel Essa, Master student
-
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Kerbala Governorate
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Karbala, Kerbala Governorate, Irak, 56001
- Rekrutacyjny
- Al-Hassan Al-Mujtaba Hospital
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Główny śledczy:
- Muslim Aqeel Essa, Master student
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Age 18-75 years.
- Scheduled for elective open-heart surgery.
- Can understand instructions and perform Segmental breathing and Active cycle breathing techniques.
- Stable preoperative hemodynamic condition.
Exclusion Criteria:
- Emergency cardiac surgeries.
- Patients with pre-existing severe pulmonary disease (e.g., COPD, asthma, restrictive lung disease, Atelectasis, and Tuberculosis).
- Neurological disorders affecting breathing effort.
- Patients with rib fractures, recent thoracic trauma, or contraindications for coughing maneuvers.
- Inability to provide informed consent (cognitive impairment, language barrier).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Segmental Breathing Exercises
Patients receive segmental breathing exercises after open heart surgery to improve lung expansion and cardiopulmonary function
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Deep breathing exercises focusing on specific lung segments to improve ventilation, lung expansion, and oxygenation in post open heart surgery patients.
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Eksperymentalny: Active Cycle Breathing Technique
Patients receive active cycle breathing technique (ACBT) after open heart surgery to enhance airway clearance and improve respiratory function.
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A combination of breathing control, thoracic expansion exercises, and forced expiration technique to improve airway clearance and lung function.
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Aktywny komparator: Standard Postoperative Care
Patients receive routine postoperative care without structured breathing exercise interventions.
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Participants will receive routine postoperative care according to institutional protocols following cardiac surgery.
This includes standard medical and nursing management such as oxygen therapy, pain control, monitoring of vital signs, and mobilization as tolerated, without additional structured respiratory physiotherapy interventions.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Oxygen Saturation (SpO₂)
Ramy czasowe: Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
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Assessment of peripheral oxygen saturation in patients after open heart surgery undergoing breathing exercises (segmental breathing exercises or active cycle breathing technique)
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Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
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Respiratory Rate
Ramy czasowe: Measurements will be obtained at baseline pre-intervention,1 hour post-intervention, and 6 hours post-intervention
|
Assessment of respiratory rate in patients after open heart surgery undergoing breathing exercises.
|
Measurements will be obtained at baseline pre-intervention,1 hour post-intervention, and 6 hours post-intervention
|
|
Heart Rate
Ramy czasowe: Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
Assessment of heart rate in patients after open heart surgery undergoing breathing exercises.
|
Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
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Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse Pressure
Ramy czasowe: Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
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Assessment of Systolic Blood Pressure Pulse Pressure, and Diastolic Blood Pressure in patients after open heart surgery undergoing breathing exercises.
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Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dyspnea Index
Ramy czasowe: measur at baseline pre-intervention and post-intervention after 6 hours.
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Assessment of dyspnea index in patients after open heart surgery using a standardized dyspnea scale contain ten questions for score 0 = Never.
1 = Almost never. 2 = Sometimes.
3 = Almost always.
4 = Always , the higher number is the worst that to evaluate changes before interventions and after implementation of segmental breathing exercises or active cycle breathing techniques.
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measur at baseline pre-intervention and post-intervention after 6 hours.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mean Arterial Pressure
Ramy czasowe: Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
Assessment of Mean Arterial Pressure in patients after open heart surgery undergoing breathing exercises.
|
Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Wafaa Abd Ali Hattab, Assist prof, College of Nursing , University of Baghdad
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
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
Dodatkowe istotne warunki MeSH
- Choroby naczyniowe
- Choroby układu krążenia
- Choroby serca
- Choroby Układu Oddechowego
- Zaburzenia oddychania
- Oznaki i objawy, układ oddechowy
- Arterioskleroza
- Choroby okluzyjne tętnic
- Choroba wieńcowa
- Niedokrwienie mięśnia sercowego
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Choroba wieńcowa
- Duszność
Inne numery identyfikacyjne badania
- UOB-NUR-2026-03
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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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