Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584825
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Enhanced Vitals Monitoring After Major Surgery Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Enhanced Postoperative Vitals Monitoring In-hospital and At Home Vs Existing In-hospital Monitoring for Medium- to High-risk Patients Undergoing Inpatient Major Abdominal and Vascular Surgery a Pilot Single-centre RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to examine the feasibility of an enhanced vital sign monitoring solution in-hospital and at-home This study includes adult patients undergoing inpatient medium- to high-risk vascular or abdominal surgery Researchers will compare the enhanced vitals monitoring group to the standard of care group to see if it may change post-operative management and outcomes The primary question it aims to answer is if enhanced monitoring of surgical patient vitals can increase the number of days at home alive in the first 30 days after surgery Participants in the intervention group will test two vitals monitoring devices one in the hospital and one at home They will also be asked to complete several questionnaires and a follow up phone call
Detailed Description:
After surgeries patients are at risk of a variety of complications thus requiring monitoring for early detection and treatment of complications The current standard of care consists of continuous monitoring of vital signs during and after anesthetic andor in the high-acuity and intensive care units followed by intermittent measurement of vital signs once the patient is in the ward Once the patient is at home there is no monitoring nor follow-up
However it has been well-established that existing intermittent monitoring of vital signs are too infrequent to capture important vital sign derangements For example in an observational study of 312 patients who underwent abdominal surgery 18 of patients had blood pressure 65 mmHg for at least 15 minutes that were not detected by conventional intermittent monitoring Nevertheless it remains unknown the optimal method and duration of increased monitoring for medium-to-high risk surgical patients in-hospital and at home In a randomized controlled trial RCT involving 905 adults undergoing non-elective surgery remote automated monitoring with virtual care did not reduce the number of days alive and at home 30 days after surgery DAH30 compared to standard of care However there are signals of increased detection of drug errors decreased pain and benefits in patients in centres with more escalations in care
This study is a single-blinded parallel-group pilot RCT with an exploratory feasibility analysis The study will be reported according to the Consolidated Standards of Reporting Trials CONSORT pilot RCT standards
The study will be conducted at St Pauls Hospital SPH Providence Health Care in Vancouver British Columbia Canada an academic tertiary care hospital affiliated with the University of British ColumbiaThe SPH anesthesia and surgical program already has a strong perioperative care focus featuring enhanced postoperative support available for high risk patients including 1 surgical high-acuity unit SHAU with continuous monitoring run by anesthesiologists 2 Perioperative Outreach Team that rounds on patients daily for as long as clinically indicated run by anesthesiologists 3 multidisciplinary collaboration and support from perioperative internal medicine andor geriatric teams with daily rounding for as long as clinically indicated and availability for preoperative consultation and post-discharge follow-up in rapid access clinics and 4 protocolized monitoring for myocardial injury after non-cardiac surgery for three days according to the Canadian Cardiovascular Society guidelines
The objective of the study is to obtain pilot data on the enhanced monitoring of vital signs in high-risk patients undergoing inpatient major abdominal andor vascular surgery ie continuous monitoring of vital signs in-hospital followed by thrice-daily monitoring at home 7 days after discharge up to a maximum of 30 days postoperatively with a protocol for care escalation if needed compared to standard monitoring intermittent monitoring in-hospital and no monitoring at home
However it has been well-established that existing intermittent monitoring of vital signs are too infrequent to capture important vital sign derangements For example in an observational study of 312 patients who underwent abdominal surgery 18 of patients had blood pressure 65 mmHg for at least 15 minutes that were not detected by conventional intermittent monitoring Nevertheless it remains unknown the optimal method and duration of increased monitoring for medium-to-high risk surgical patients in-hospital and at home In a randomized controlled trial RCT involving 905 adults undergoing non-elective surgery remote automated monitoring with virtual care did not reduce the number of days alive and at home 30 days after surgery DAH30 compared to standard of care However there are signals of increased detection of drug errors decreased pain and benefits in patients in centres with more escalations in care
This study is a single-blinded parallel-group pilot RCT with an exploratory feasibility analysis The study will be reported according to the Consolidated Standards of Reporting Trials CONSORT pilot RCT standards
The study will be conducted at St Pauls Hospital SPH Providence Health Care in Vancouver British Columbia Canada an academic tertiary care hospital affiliated with the University of British ColumbiaThe SPH anesthesia and surgical program already has a strong perioperative care focus featuring enhanced postoperative support available for high risk patients including 1 surgical high-acuity unit SHAU with continuous monitoring run by anesthesiologists 2 Perioperative Outreach Team that rounds on patients daily for as long as clinically indicated run by anesthesiologists 3 multidisciplinary collaboration and support from perioperative internal medicine andor geriatric teams with daily rounding for as long as clinically indicated and availability for preoperative consultation and post-discharge follow-up in rapid access clinics and 4 protocolized monitoring for myocardial injury after non-cardiac surgery for three days according to the Canadian Cardiovascular Society guidelines
The objective of the study is to obtain pilot data on the enhanced monitoring of vital signs in high-risk patients undergoing inpatient major abdominal andor vascular surgery ie continuous monitoring of vital signs in-hospital followed by thrice-daily monitoring at home 7 days after discharge up to a maximum of 30 days postoperatively with a protocol for care escalation if needed compared to standard monitoring intermittent monitoring in-hospital and no monitoring at home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None