Use of Wearables for Early Detection of Complications After Major Acute Abdominal Surgery

NCT04257344 | Completed

• 1 other identifier: REG-071-2019
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate whether glucose profile, sleep disturbances and heart rate variability measured with wearable devices is associated with postoperative recovery and complications within 30 days after major emergency abdominal surgery. The study is designed as an explorative, prospective cohort study. 40 patients undergoing major emergency abdominal surgery at Zealand's University Hospital Køge are included in the study, and inclusion occurs within 24 hours of end of surgery. Patients will be followed for 30 days, and three scheduled study visits are planned during follow up at postoperative day 10, 20 and 30. Glucose is measured continuously with a wearable subcutaneous sensor (Dexcom G6). Glucose readings are validated in the perioperative setting using blood glucose measurements obtained with standard finger-pricks 3-5 times a day during hospitalization. Actigraphy is used for assessing sleep- and activity patterns for the full study period. Heart rate variation is measured with a compact Holter monitor. Furthermore, the study assesses patient-reported quality of recovery, glucose metabolism, nutritional status and mobility. Various data on demographics, peri- and postoperative data will be extracted from the electronic patient chart.

Conditions

Surgery--Complications; Abdomen Disease

Keywords

Wearables; Emergency surgery; Abdominal surgery; Patient reported outcome measures; Recovery; Continues Glucose Monitoring; Heart Rate Variation; Actigraphy; Sleep; Quality of Recovery

Outcome Measures

Primary Outcomes (5)

• Quality of Recovery-15 score

  The score is based on 15 questions with a maximum total score of 150 indicating excellent patient-reported recovery

  30 days

• Heart rate variation

  Heart rate variation measured with wearable devices. Time domain measures are used.

  7 days post discharge or maximum 14 days after surgery

• Total Sleep Time

  Total time of sleep during 24 hours, assessed with actigraphy

  30 days

• Sleep Efficiency

  The ratio of the total sleep time compared to the total time spent in bed during 24 hours

  30 days

• Mean amplitude of glucose excursions (MAGE)

  Measure of within-day glycemic variability assessed with continues glucose monitoring

  30 days

Secondary Outcomes (7)

• Time in bed

  30 days

• Wake Time

  30 days

• Wake after Sleep Onset (WASO)

  30 days

• Number of awakenings

  30 days

• Time in range

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the study population consists of all patients admitted at Zealands University Hospital Køge, who undergo major emergency abdominal surgery.

You may qualify if:

• Patients undergoing major emergency abdominal surgery including laparotomy or laporoscopy. Indications include ileus, perforated hollow organ, intraabdominal bleeding, ischemia, wound dehiscence.

You may not qualify if:

• Laparoscopic surgeries for diseases related to appendix, gall bladder or bile ducts are excluded, unless the procedure is converted to open surgery perioperative.
• not understanding or speeking danish
• cognitive dysfunction
• chronic immobilization
• pregnancy
• diabetes (type I and II)
• Permanent atrial fibrillation or pacemaker

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Surgical department, Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (8)

• Monnier L, Colette C, Owens DR. The application of simple metrics in the assessment of glycaemic variability. Diabetes Metab. 2018 Sep;44(4):313-319. doi: 10.1016/j.diabet.2018.02.008. Epub 2018 Mar 6.

  PMID: 29602622 BACKGROUND

• Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.

  PMID: 29162583 BACKGROUND

• Berger AM, Wielgus KK, Young-McCaughan S, Fischer P, Farr L, Lee KA. Methodological challenges when using actigraphy in research. J Pain Symptom Manage. 2008 Aug;36(2):191-9. doi: 10.1016/j.jpainsymman.2007.10.008. Epub 2008 Apr 8.

  PMID: 18400460 BACKGROUND

• Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

  PMID: 8737210 BACKGROUND

• Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.

  PMID: 23471753 BACKGROUND

• Wallace TM, Levy JC, Matthews DR. Use and abuse of HOMA modeling. Diabetes Care. 2004 Jun;27(6):1487-95. doi: 10.2337/diacare.27.6.1487.

  PMID: 15161807 BACKGROUND

• Beer-Borst S, Amado R. Validation of a self-administered 24-hour recall questionnaire used in a large-scale dietary survey. Z Ernahrungswiss. 1995 Sep;34(3):183-9. doi: 10.1007/BF01623156.

  PMID: 7502539 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

Study Officials

• Johan Johan, MD

  Surgical department, Zealands University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: February 6, 2020
• Study Start: October 1, 2019
• Primary Completion: January 22, 2021
• Study Completion: February 20, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

DK (1)