Predictor of Postoperative Complications After Lengthy Noncardiac Surgery

Completed

• Conditions: Peripheral Perfusion Index
• Interventions: Diagnostic Test: Peripheral Perfusion index; Diagnostic Test: serum lactate level

• Registration Number: NCT04680663
• Lead Sponsor: Cairo University

Brief Summary

Many patients undergoing long time surgery will manifest increased level of blood lactate.

Hyperlactacidemia can cause disturbance of internal environment, then leading to increased complications and longer ICU stay, even death. For postoperative patients, we must ensure adequate perfusion in order to minimize the length of hyperglycemia and improve patients' outcomes. With regard to lactate, it provides information about prefusion, but not timely enough for its delay on reflecting hypoperfusion. And it's not real-time and non-invasive.

Peripheral perfusion index (PPI) is an indicator reflecting hypoperfusion in critical patients. It is measured using pulse co-oximetry technology which is characterized by being real-time and noninvasive. PPI is defined as "the ratio of pulsatile blood flow to the non-pulsatile blood flow", mirroring the strength of blood flow and quality of perfusion at sensor site, reflecting perfusion state of the body part . In contrast to lactate value, it's real-time and easy to monitor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-03-15
• Primary Completion: 2024-05-12
• Study Completion: 2024-06-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-severe complications group	serum lactate level	where the non-complicated patients is the patients running the normal postoperative course of surgery and without any need for intervention
severe complications group	serum lactate level	any deviation from the normal post-operative course
Non-severe complications group	Peripheral Perfusion index	where the non-complicated patients is the patients running the normal postoperative course of surgery and without any need for intervention
severe complications group	Peripheral Perfusion index	any deviation from the normal post-operative course

Primary Outcome Measures

Name	Time	Method
Peripheral perfusion index	up to 48 hours	at end of surgery as early predictor of postoperative complications .
serum lactate level	up do 48 hours	at end of surgery as early predictor of postoperative complications .

Secondary Outcome Measures

Name	Time	Method
serum lactate level	UP TO 30 day	at end of surgery as early predictor of postoperative complications .
Peripheral perfusion index	UP TO 30 DAY	at end of surgery as predictor seversity of postoperative complications .
Postoperative complications	up to 30 day	the Clavien-Dindo classification system Grade I complications Grade II complications Grade III complications Grade IV complications
hemodynamic change	up do 48 hours	mean arterial blood pressure
heart rate	up do 48 hours	hemodynamic change

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt