- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Muslim Aqeel Essa, Master Student
- Telefonní číslo: +9647822218483
- E-mail: muslim.eesa2402m@conursing.uobaghdad.edu.iq
Studijní záloha kontaktů
- Jméno: Rusul Khalid Kadhim, Master Student
Studijní místa
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Irák, 10001
- Nábor
- Ibn Al-Bitar Specialized Hospital for Cardiac Surgery
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Vrchní vyšetřovatel:
- Muslim Aqeel Essa, Master student
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Baghdad, Baghdad Governorate, Irák, 10001
- Nábor
- Iraqi Center for Heart Diseases
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Vrchní vyšetřovatel:
- Muslim Aqeel Essa, Master student
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Kerbala Governorate
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Karbala, Kerbala Governorate, Irák, 56001
- Nábor
- Al-Hassan Al-Mujtaba Hospital
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Vrchní vyšetřovatel:
- Muslim Aqeel Essa, Master student
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Experimentální: 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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Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Oxygen Saturation (SpO₂)
Časové okno: 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
Časové okno: Measurements will be obtained at baseline pre-intervention,1 hour post-intervention, and 6 hours post-intervention
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Assessment of respiratory rate 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
|
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Heart Rate
Časové okno: 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 heart rate 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
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Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse Pressure
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dyspnea Index
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean Arterial Pressure
Časové okno: 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 Mean Arterial 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Wafaa Abd Ali Hattab, Assist prof, College of Nursing , University of Baghdad
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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 relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Srdeční choroba
- Nemoci dýchacích cest
- Poruchy dýchání
- Příznaky a symptomy, Respirační
- Arterioskleróza
- Arteriální okluzivní onemocnění
- Koronární onemocnění
- Ischémie myokardu
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Ischemická choroba srdeční
- Dušnost
Další identifikační čísla studie
- UOB-NUR-2026-03
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