- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Muslim Aqeel Essa, Master Student
- Puhelinnumero: +9647822218483
- Sähköposti: muslim.eesa2402m@conursing.uobaghdad.edu.iq
Tutki yhteystietojen varmuuskopiointi
- Nimi: Rusul Khalid Kadhim, Master Student
Opiskelupaikat
-
-
Baghdad Governorate
-
Baghdad, Baghdad Governorate, Irak, 10001
- Rekrytointi
- Ibn Al-Bitar Specialized Hospital for Cardiac Surgery
-
Päätutkija:
- Muslim Aqeel Essa, Master student
-
Baghdad, Baghdad Governorate, Irak, 10001
- Rekrytointi
- Iraqi Center for Heart Diseases
-
Päätutkija:
- Muslim Aqeel Essa, Master student
-
-
Kerbala Governorate
-
Karbala, Kerbala Governorate, Irak, 56001
- Rekrytointi
- Al-Hassan Al-Mujtaba Hospital
-
Päätutkija:
- Muslim Aqeel Essa, Master student
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Oxygen Saturation (SpO₂)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Dyspnea Index
Aikaikkuna: 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.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mean Arterial Pressure
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Wafaa Abd Ali Hattab, Assist prof, College of Nursing , University of Baghdad
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- UOB-NUR-2026-03
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .