Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013891
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2023-07-07
Brief Title:
Observational Study of Early Postoperative Deterioration and Complications
Sponsor:
Copenhagen University Hospital Hvidovre
Organization:
Copenhagen University Hospital Hvidovre
Study Overview
Official Title:
The Incidence and Association of PACU Course and Early Postoperative Complications and Deterioration
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective observational research project aims to investigate how vital sign deterioration and complications within the PACU relate to early deterioration and complications in the surgical wards 72 hours post-PACU discharge
The participants studied will be high-risk surgical patients who will follow a normal postoperative course from the PACU to the surgical ward The investigators seek to evaluate the association between deterioration and complications within the PACU with vital signs deterioration and complications in the surgical wards Second the investigators will explore how deterioration and complications affect PACU length of stay morbidity mortality rapid response Teams call-outs RRT Early warning score 7 extra medical patient supervision and unplanned intensive care unit ICU admissions The investigators will also examine the nurses assessment of the patients risk of deterioration and complications upon discharge from the PACU and admission to the surgical department
The participants studied will be high-risk surgical patients who will follow a normal postoperative course from the PACU to the surgical ward The investigators seek to evaluate the association between deterioration and complications within the PACU with vital signs deterioration and complications in the surgical wards Second the investigators will explore how deterioration and complications affect PACU length of stay morbidity mortality rapid response Teams call-outs RRT Early warning score 7 extra medical patient supervision and unplanned intensive care unit ICU admissions The investigators will also examine the nurses assessment of the patients risk of deterioration and complications upon discharge from the PACU and admission to the surgical department
Detailed Description:
Postoperative complications are increasing and are an under-recognized cause of morbidity and mortality While there has been significant attention to preoperative risk assessments for late postoperative complications and 30-day mortality little attention has been paid to the PACU as a point of in-patient triage for early postoperative deterioration and complications PACU to surgical ward discharge readiness is often based on a quantitative discharge score that does not account for the patients physiological responses or distinguish between surgery type age and co-morbidities
The discharge score is a clinical decision-making tool that sets the frame for the patients readiness for discharge and functions as a one six fits all system However this one size fits all approach may not be adequate as a discharge tool when discharging high-risk fragile patients from the PACU The current evidence on using criterion-based discharge scores and the connection with early postoperative deterioration and complications are absent and need further investigation
It is unclear whether early postoperative deterioration and complications can be predicted and assessed during PACU stay Thus leaving a big potential for improvement in patient assessment and detection of early deterioration and complications improving safe PACU discharge for high-risk fragile patients Providing new knowledge on early postoperative deterioration and complications within high-risk fragile patient groups could improve postoperative courses and patient safety
Statistical analysis plan Data is expected to be divided into two or 3 consecutive studies
The discharge score is a clinical decision-making tool that sets the frame for the patients readiness for discharge and functions as a one six fits all system However this one size fits all approach may not be adequate as a discharge tool when discharging high-risk fragile patients from the PACU The current evidence on using criterion-based discharge scores and the connection with early postoperative deterioration and complications are absent and need further investigation
It is unclear whether early postoperative deterioration and complications can be predicted and assessed during PACU stay Thus leaving a big potential for improvement in patient assessment and detection of early deterioration and complications improving safe PACU discharge for high-risk fragile patients Providing new knowledge on early postoperative deterioration and complications within high-risk fragile patient groups could improve postoperative courses and patient safety
Statistical analysis plan Data is expected to be divided into two or 3 consecutive studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None