Preoperative Walking Evaluation and Postoperative Outcome

General Surgery Clinical Trial

— PREVENT  

Official title:

Preoperative Walking Evaluation and Postoperative Outcome in Non-cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023069
• Other study ID #: N32276 PMI/Karolinska
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: Max Bell, MD, PhD
• Phone: +46708278533
• Email: max.bell[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The hypothesis is that physical activity is associated with a reduced risk of complications and death after surgery.

Self-reporting of physical activity is prone to be unreliable. In order to obtain a better picture of patients' physical activity, we intend to investigate the association between the average number of steps and postoperative outcomes. Many other objective measures of physical activity are costly and time-consuming to perform; for example, exercise tests, extensive sampling, and longer questionnaires.

The primary research question is: Do patients with a higher degree of physical activity, measured as the average number of steps recorded on the patient's mobile phone, have a reduced risk of peri/postoperative complications and death, measured as Days At Home alive at 30 days (DAH30)?

Secondary research questions include:

Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, linearly linked to DAH30? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, associated with specific peri/postoperative organ impact, such as lung, heart, cerebral, infection, or kidney complications? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, also linked to long-term outcomes one year after surgery? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, solely associated with DAH30 and organ complications for specific patient groups in terms of age, comorbidities, and/or type of surgery?

Description:

Project Description Method This is a non-interventional prospective observational multicenter study of the association between physical activity and peri/postoperative outcomes, planned to be conducted in two stages. First, as a pilot study involving multiple participating anesthesia/surgery clinics. Following this, the plan is to analyze data from the mentioned pilot study and then launch a global multicenter study on a more defined patient group.

Procedures/Data Collection Preoperatively: The investigators will record age, gender, comorbidities, and ongoing medication, as well as ASA classification, frailty score, and mDASI (modified Duke Activity Status Index), which is a measure of functional ability. Routine preoperative laboratory tests will be noted. Furthermore, the investigators intend to record average physical activity, including daily step count on average at one, six, and twelve months before surgery, based on data from the patient's mobile phone*. Type of planned surgery will be recorded.

*The dominant mobile phones on the market (iOS and Android-based) use different types of systems to count steps. Some mobile phones completely lack such systems. The validation of how accurately they count steps per day also varies. We will record the model and operating system, as well as the type of app used. Not all patients carry their phones all the time; we intend to register their own estimate of how often it is carried. A few patients do not have a mobile phone and cannot contribute step per day data.

Intraoperatively: The investigators will record anesthesia method, operation time (incision time and total operation time), fluid balance, bleeding, and transfusion requirements, as well as adverse events such as blood pressure drops, hypoxia, tachycardia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery providing informed consent

Exclusion Criteria:

Patients that can not provide informed consent.

Related Conditions & MeSH terms

• General Surgery

Intervention

Other:
• Number of steps recorded by mobile phone as a proxy for physical activity
This cohort is likely to have patients with many steps/day (high activity) and few steps/day (low activity)

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAH30 (Days At Home alive at 30 days)	DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16. Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14. Anyone who dies within 30 days will have DAH30=0. This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS)	30 days after index surgery
Secondary	Mortality	Death within the time frames described below	Mortality will be recorded at 30, 60, 90 and 365 days after index surgery