Effects of E-care Protocol in Patients With Coronary Artery Bypass Graft

Официальное название

Effects of E-care Protocol in Length of Hospital Stay and Respiratory Failure in Patients With Coronary Artery Bypass Graft

Обзор

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.

Подробное описание

The study will be randomized clinical trial. It will be conducted at Gulab Devi Chest Hospital Lahore, Pakistan. Total sample size will be 42. Attrition rate is 10%. The data will be analyzed using SPSS v25. Sample size will be conducted via non probability consecutive sampling technique as per inclusion criteria participants will be randomly assigned into two groups. 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. Group B will receive E- CARE protocol with IMT threshold device to improve respiratory muscle strength. This study focuses on the LOHS and the incidence of respiratory failure.

Вмешательства

• Устройство IMT Threshold device
  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

Первичные конечные точки

• change in Length of stay [Срок оценки: Total days 7]

Критерии участия

Критерии включения

• 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 .

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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• Rajaei S, Dabbagh A. Risk factors for postoperative respiratory mortality and morbidity in patients undergoing coronary artery bypass grafting. Anesth Pain Med. 2012 Fall;2(2):60-5. doi: 10.5812/aapm.5228. Epub 2012 Sep 13. PMID 24223339
• Deb S, Wijeysundera HC, Ko DT, Tsubota H, Hill S, Fremes SE. Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. JAMA. 2013 Nov 20;310(19):2086-95. doi: 10.1001/jama.2013.281718. PMID 24240936
• 11. Kazem, S.S., et al., Pulmonary physiotherapy effect on patients undergoing open cardiac surgery. Russian open medical journal, 2014. 3(3): p. 306.
• Head SJ, Milojevic M, Daemen J, Ahn JM, Boersma E, Christiansen EH, Domanski MJ, Farkouh ME, Flather M, Fuster V, Hlatky MA, Holm NR, Hueb WA, Kamalesh M, Kim YH, Makikallio T, Mohr FW, Papageorgiou G, Park SJ, Rodriguez AE, Sabik JF 3rd, Stables RH, Stone GW, Serruys PW, Kappetein AP. Stroke Rates Following Surgical Versus Percutaneous Coronary Revascularization. J Am Coll Cardiol. 2018 Jul 24;72 PMID 30025574
• Zanini M, Nery RM, de Lima JB, Buhler RP, da Silveira AD, Stein R. Effects of Different Rehabilitation Protocols in Inpatient Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):E19-E25. doi: 10.1097/HCR.0000000000000431. PMID 31343586
• Tajti P, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Burke MN, Doing AH, Dattilo P, Toma C, Smith AJC, Uretsky B, Holper E, Potluri S, Wyman RM, Kandzari DE, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Jaber W, Samady H, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Xenogiannis I, Stanberry LI, Rangan BV, Ungi I, Banerjee S, Brilaki PMID 30871357
• Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: Executive Summary: A Rep PMID 34895951

Идентификаторы

NCT: NCT07574411 · Laiba rani · 64146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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