Predictor of Postoperative Complications After Lengthy Noncardiac Surgery

NCT04680663 | Completed DMC

• 1 other identifier: MS-390-2020
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Perfusion Index

Outcome Measures

Primary Outcomes (2)

• Peripheral perfusion index

  at end of surgery as early predictor of postoperative complications .

  up to 48 hours

• serum lactate level

  at end of surgery as early predictor of postoperative complications .

  up do 48 hours

Secondary Outcomes (5)

• serum lactate level

  UP TO 30 day

• Peripheral perfusion index

  UP TO 30 DAY

• Postoperative complications

  up to 30 day

• hemodynamic change

  up do 48 hours

• heart rate

  up do 48 hours

Study Arms (2)

Non complications group

where the non-complicated patients is the patients running the normal postoperative course of surgery and without any need for intervention

Diagnostic Test: Peripheral Perfusion index; Diagnostic Test: serum lactate level

complications group

any deviation from the normal post-operative course

Diagnostic Test: Peripheral Perfusion index; Diagnostic Test: serum lactate level

Interventions

Peripheral Perfusion index DIAGNOSTIC_TEST

Peripheral Perfusion index is the ratio between pulsatile blood flow to non pulsatile blood flow or static blood in the peripheral tissue

Non complications group; complications group

serum lactate level DIAGNOSTIC_TEST

Blood lactate (product of metabolism) level is maintained by a cycle of continuous production and metabolism allowing it to be kept within normal values

Non complications group; complications group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be designed to recruit patients scheduled for elective surgery with duration \> 120 minutes under general anaesthesia

You may qualify if:

• Adult patients above 18 years of age.
• Both genders
• surgical time planned to be \> 120 minutes .
• surgical time predicted to exceed the planned time and prolongation of surgical time \> 120 minutes occured will be included in the study .
• ASA physical status of I-II
• Patients scheduled for elective surgery under general anaesthesia .

You may not qualify if:

• Refused to participate .
• patient with disease affecting blood flow to the hands where probe will be applied .
• patient with hand injuries so probe cannot be applied
• Patient with sever renal and liver disease
• Discharging against medical advice or reported death during ICU stay at first 48 hours after ICU admission .
• Pregnancy or emergency surgery .
• shortening of the planned surgical time to be less than 120 minutes

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, 11451, Egypt

Location

Study Officials

• Amr s wahdan, MD

  Cairo university , Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Pain management and Surgical ICU

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: March 15, 2021
• Primary Completion: May 12, 2024
• Study Completion: June 10, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (1)