- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Muslim Aqeel Essa, Master Student
- Numero di telefono: +9647822218483
- Email: muslim.eesa2402m@conursing.uobaghdad.edu.iq
Backup dei contatti dello studio
- Nome: Rusul Khalid Kadhim, Master Student
Luoghi di studio
-
-
Baghdad Governorate
-
Baghdad, Baghdad Governorate, Iraq, 10001
- Reclutamento
- Ibn Al-Bitar Specialized Hospital for Cardiac Surgery
-
Investigatore principale:
- Muslim Aqeel Essa, Master student
-
Baghdad, Baghdad Governorate, Iraq, 10001
- Reclutamento
- Iraqi Center for Heart Diseases
-
Investigatore principale:
- Muslim Aqeel Essa, Master student
-
-
Kerbala Governorate
-
Karbala, Kerbala Governorate, Iraq, 56001
- Reclutamento
- Al-Hassan Al-Mujtaba Hospital
-
Investigatore principale:
- Muslim Aqeel Essa, Master student
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Segmental Breathing Exercises
Patients receive segmental breathing exercises after open heart surgery to improve lung expansion and cardiopulmonary function
|
Deep breathing exercises focusing on specific lung segments to improve ventilation, lung expansion, and oxygenation in post open heart surgery patients.
|
|
Sperimentale: Active Cycle Breathing Technique
Patients receive active cycle breathing technique (ACBT) after open heart surgery to enhance airway clearance and improve respiratory function.
|
A combination of breathing control, thoracic expansion exercises, and forced expiration technique to improve airway clearance and lung function.
|
|
Comparatore attivo: Standard Postoperative Care
Patients receive routine postoperative care without structured breathing exercise interventions.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Oxygen Saturation (SpO₂)
Lasso di tempo: Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
Assessment of peripheral oxygen saturation in patients after open heart surgery undergoing breathing exercises (segmental breathing exercises or active cycle breathing technique)
|
Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
|
Respiratory Rate
Lasso di tempo: 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
Lasso di tempo: 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
|
|
Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse Pressure
Lasso di tempo: Measurements will be obtained at baseline pre-intervention, 1 hour post-intervention, and 6 hours post-intervention during hospital stay
|
Assessment of Systolic Blood Pressure Pulse Pressure, and Diastolic Blood 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dyspnea Index
Lasso di tempo: measur at baseline pre-intervention and post-intervention after 6 hours.
|
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.
|
measur at baseline pre-intervention and post-intervention after 6 hours.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Arterial Pressure
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Wafaa Abd Ali Hattab, Assist prof, College of Nursing , University of Baghdad
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Malattie cardiache
- Malattie delle vie respiratorie
- Disturbi respiratori
- Segni e sintomi, respiratori
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattia coronarica
- Ischemia miocardica
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Disfunsione dell'arteria coronaria
- Dispnea
Altri numeri di identificazione dello studio
- UOB-NUR-2026-03
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .