Postoperative Respiratory and Activity Monitoring

Обзор

This study plans to learn more about specific breathing and activity recommendations for patients after surgery. Participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.

Подробное описание

Investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications.

Participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. These monitors will be placed on their skin in the Post-Anesthesia Care Unit (PACU) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. Investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.

Вмешательства

• Устройство ExSpiron and ActivPAL Monitors
  ExSpiron chest monitor will be placed on the chest ActivPAL accelerometer will be placed on the chest and thigh

Первичные конечные точки

• Hypoventilation [Срок оценки: First 3 postoperative days]

Вторичные конечные точки (12)

• Variability of MV [Срок оценки: Through postoperative day 3]
• Variability of VT [Срок оценки: Through postoperative day 3]
• Variability of RR [Срок оценки: Through postoperative day 3]
• Events of Low MV [Срок оценки: Through postoperative day 3]
• Events of Low VT [Срок оценки: Through postoperative day 3]
• Events of Low RR [Срок оценки: Through postoperative day 3]
• Percentage of time free of low or high MV [Срок оценки: Through postoperative day 3]
• Percentage of time free of low or high VT [Срок оценки: Through postoperative day 3]
• Percentage of time free of low or high RR [Срок оценки: Through postoperative day 3]
• Duration of low MV [Срок оценки: Through postoperative day 3]
• Duration of low VT [Срок оценки: Through postoperative day 3]
• Duration of low RR [Срок оценки: Through postoperative day 3]

Критерии участия

Критерии включения

• Must be 18 or older
• Must be undergoing abdominal surgery
• Must be high-risk for PPCs (ARISCAT score equal to or greater than 26)

Критерии исключения

• Anyone under 18
• Anyone not undergoing abdominal surgery
• Anyone that is not high-risk for PPCs (ARISCAT score less than 26)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• UC Health — Aurora

Публикации

• Fernandez-Bustamante A, Parker RA, Sprung J, Eikermann M, Gama de Abreu M, Ferrando C, Thompson BT, Vidal Melo MF. An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol. PLoS One. 2023 Apr 6;18(4):e0283748. doi: 10.1371/journal.pone.0283748. eCollection 2023. PMID 37023031
• Lawrence VA, Hilsenbeck SG, Mulrow CD, Dhanda R, Sapp J, Page CP. Incidence and hospital stay for cardiac and pulmonary complications after abdominal surgery. J Gen Intern Med. 1995 Dec;10(12):671-8. doi: 10.1007/BF02602761. PMID 8770719
• Fernandez-Perez ER, Sprung J, Afessa B, Warner DO, Vachon CM, Schroeder DR, Brown DR, Hubmayr RD, Gajic O. Intraoperative ventilator settings and acute lung injury after elective surgery: a nested case control study. Thorax. 2009 Feb;64(2):121-7. doi: 10.1136/thx.2008.102228. Epub 2008 Nov 6. PMID 18988659
• Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. PMID 21045639
• Shander A, Fleisher LA, Barie PS, Bigatello LM, Sladen RN, Watson CB. Clinical and economic burden of postoperative pulmonary complications: patient safety summit on definition, risk-reducing interventions, and preventive strategies. Crit Care Med. 2011 Sep;39(9):2163-72. doi: 10.1097/CCM.0b013e31821f0522. PMID 21572323
• Nijbroek SG, Schultz MJ, Hemmes SNT. Prediction of postoperative pulmonary complications. Curr Opin Anaesthesiol. 2019 Jun;32(3):443-451. doi: 10.1097/ACO.0000000000000730. PMID 30893115
• Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216. PMID 24755786
• Sabate S, Mazo V, Canet J. Predicting postoperative pulmonary complications: implications for outcomes and costs. Curr Opin Anaesthesiol. 2014 Apr;27(2):201-9. doi: 10.1097/ACO.0000000000000045. PMID 24419159

Идентификаторы

NCT: NCT06239831 · 22-2268

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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