- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07574411
Effects of E-care Protocol in Patients With Coronary Artery Bypass Graft (CABG)
Effects of E-care Protocol in Length of Hospital Stay and Respiratory Failure in Patients With Coronary Artery Bypass Graft
Coronary artery disease (CAD) is a heart disease caused by the buildup of plaque inside the coronary arteries that restricts blood flow to the heart which leads to heart attack. If it involve more than one artery it will be more critical so the preferred treatment will be coronary artery bypass graft. Respiratory failure after Coronary Artery Bypass Grafting (CABG) is a serious complication with multifactorial causes i.e. pneumonia and atelectasis in inpatients.
Postoperative pulmonary complications will be diagnosed using the Melbourne Group Scale (MGS), applied daily from postoperative day 1 to day 7. A score of ≥4 positive criteria will be used to identify PPCs. The scale's criteria will include chest radiograph findings, oxygen saturation, sputum characteristics, inflammatory markers, and ventilation data, physician diagnosis of pneumonia, readmission to ICU for respiratory reasons, prolong ventilation> 24 hours, unplanned use of non-invasive ventilation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Laiba Rani, MS CPPT
- Telefonnummer: 03498009007
- E-mail: dr.laiba0303@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Male and female of >45 years diagnosed with CAD and are undergone Coronary Artery Bypass Graft with stable circulation.
- Stable vitals.
- With normal cognition and being able to cooperate with the CR training.
- Agreed to participate in the trial and signed the consent for .
Exclusion Criteria:
- Pregnant
- Undergoing aortic surgery or equivalent surgery within 6 months
- History of cardiogenic shock or sudden cardiac arrest and severe hypertension
- Having complications with persistent ischemia, hemodynamic impairment, or at risk of arterial occlusion with massive myocardial infarction
- Having complications with unstable angina, malignant arrhythmia
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Gruppe B
|
Group A will receive standard rehabilitation treatment for inpatients. This includes the physical reconditioning, promote patient independence, Provide education about lifestyle changes and respiratory muscle strength. For example Day 1-2(Sitting up in bed or in a chair, Breathing exercises (incentive spirometer) and Coughing with pillow support (to protect the sternum).Day 2-3(Standing and walking short distances with assistance and Gentle range-of- motion (ROM) exercises. Day 4-5 (Walk longer distances (50-100 meters) and Stair climbing (if appropriate). It's necessary to monitor the vital signs (HR, BP, O2 saturation), pain levels, wound inspection and signs of orthostatic intolerance or arrhythmias. 6.1 IMT (Inspiratory muscle training) via use of IMT threshold Device: In comfortable sitting position IMT threshold device will be applied to the patient. Device will properly fitted to the patients mouth and set the resistance according to the patient respiratory muscle strength af
Andre navne:
|
|
Ingen indgriben: Group A
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
change in Length of stay
Tidsramme: Total days 7
|
Length of stay in ward will be noted
|
Total days 7
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wajeeha Zia, phd, Riphah International University
Publikationer og nyttige links
Generelle publikationer
- 14. Maisel, W.H., J.D. Rawn, and W.G.J.A.o.i.m. Stevenson, Atrial fibrillation after cardiac surgery. 2001. 135(12): p. 1061-1073.
- 13. Rajaei, S. and A. Dabbagh, Risk factors for postoperative respiratory mortality and morbidity in patients undergoing coronary artery bypass grafting. Anesthesiology and Pain Medicine, 2012. 2(2): p. 60.
- 12. Deb, S., et al., Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. Jama, 2013. 310(19): p. 2086-2095.
- 11. Kazem, S.S., et al., Pulmonary physiotherapy effect on patients undergoing open cardiac surgery. Russian open medical journal, 2014. 3(3): p. 306.
- 10. Head, S.J., et al., Stroke rates following surgical versus percutaneous coronary revascularization. 2018. 72(4): p. 386-398
- 9. Zanini, M., et al., Effects of different rehabilitation protocols in inpatient cardiac rehabilitation after coronary artery bypass graft surgery: a randomized clinical trial. Journal of cardiopulmonary rehabilitation and prevention, 2019. 39(6): p. E19-E25.
- 8. Tajti, P., et al., In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients with Prior Coronary Artery Bypass Graft Surgery: Insights From an International Multicenter Chronic Total Occlusion Registry. Circulation: Cardiovascular Interventions, 2019. 12(3): p. e007338.
- 7. Members, W.C., et al., 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of the American College of Cardiology, 2022. 79(2): p. 197-215
- 6. Zhang, S., et al., The effects of inspiratory muscle training (IMT) on patients undergoing coronary artery bypass graft (CABG) surgery: a systematic review and meta-analysis. 2023. 24(1): p. 16.
- 5. Hochman, J.S., et al., Survival after invasive or conservative management of stable coronary disease. Circulation, 2023. 147(1): p. 8-19.
- 4. Fernandes, G.C., et al., Determinants of early and late in-hospital mortality after acute myocardial infarction: a subanalysis of the OBTAIN registry. 2023. 39(4): p. 531-537.
- 3. Redfors, B., et al., Outcomes according to coronary revascularization modality in the ISCHEMIA trial. 2024. 83(5): p. 549-558.
- 2. Araújo, C.O., et al., Inspiratory muscle training in phase 1 and 2 postoperative cardiac rehabilitation following coronary artery bypass graft surgery: systematic review with meta- analysis. Physical therapy, 2024. 104(7): p. pzae061.
- 1. Yang Q, Wang L, Zhang X, Lu P, Pan D, Li S, Ling Y, Zhi X, Xia L, Zhu Y, Chen Y. Impact of an enhanced recovery after surgery program integrating cardiopulmonary rehabilitation on post-operative prognosis of patients treated with CABG: protocol of the ERAS-CaRe randomized controlled trial. BMC Pulmonary Medicine. 2024 Oct 14;24(1):512.Villareal, R.P., et al., Postoperative atrial fibrillation and mortality after coronary artery bypass surgery. 2004. 43(5): p. 742-748.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Laiba rani
- 64146 (Anden identifikator: riphah international university)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med CABG
-
China National Center for Cardiovascular DiseasesRekrutteringCABG | Kardiovaskulær kirurgi | Kirurger | Kunstig intelligens (AI) | CABG-patienterKina
-
Sawanpracharak hospitalIkke rekrutterer endnu
-
Riphah International UniversityAfsluttet
-
National University Hospital, SingaporeWellcome Leap Inc.Rekruttering
-
Johns Hopkins UniversityAfsluttet
-
University of VirginiaUkendt
-
University of JordanJordanian Royal Medical ServicesAfsluttet
-
Kerckhoff KlinikAfsluttetCABG-graftintegritetTyskland
-
Medistim ASAIkke rekrutterer endnuHjertebypasskirurgi (CABG)
-
Technion, Israel Institute of TechnologyAfsluttet
Kliniske forsøg med IMT Threshold device
-
Hospital de Clinicas de Porto AlegreAfsluttet
-
Biruni UniversityThe Scientific and Technological Research Council of TurkeyAfsluttetSund og raskTyrkiet (Türkiye)
-
University of FloridaAfsluttet
-
Universitas PadjadjaranDr. Hasan Sadikin General Hospital, Bandung, IndonesiaIkke rekrutterer endnuKronisk obstruktiv lungesygdom (KOL) | Diafragma dysfunktion
-
Cairo UniversityRekrutteringIntensiv afdeling erhvervet svaghedEgypten
-
Clínica BasileaIkke rekrutterer endnuFysioterapimetoder, åndedrætsmuskler, maksimalt åndedrætstryk, vejrtrækningsøvelser
-
Radboud University Medical CenterAfsluttetInspirerende muskeltræning | Nemaline myopatiHolland
-
Universitair Ziekenhuis BrusselHasselt University; Jessa HospitalTrukket tilbageFysioterapi | Koronararterie bypass transplantatkirurgi | Udskiftning af ventil | Post-Op komplikationer
-
University of ValenciaAfsluttetSarkopeni | Syndrom; InstitutionaliseringSpanien
-
Ospedali Riuniti TriesteAfsluttet