- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Laiba Rani, MS CPPT
- Telefonnummer: 03498009007
- E-post: dr.laiba0303@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Grupp 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
Andra namn:
|
|
Inget ingripande: Group A
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change in Length of stay
Tidsram: Total days 7
|
Length of stay in ward will be noted
|
Total days 7
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Wajeeha Zia, phd, Riphah International University
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Laiba rani
- 64146 (Annan identifierare: riphah international university)
Plan för individuella deltagardata (IPD)
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