Predictor of Postoperative Complications After Lengthy Noncardiac Surgery

NCT ID: NCT04680663

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-15

Study Completion Date

2024-06-10

Brief Summary

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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

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Conditions

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Peripheral Perfusion Index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non complications group

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

Peripheral Perfusion index

Intervention Type DIAGNOSTIC_TEST

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

serum lactate level

Intervention Type 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

complications group

any deviation from the normal post-operative course

Peripheral Perfusion index

Intervention Type DIAGNOSTIC_TEST

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

serum lactate level

Intervention Type 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

Interventions

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Peripheral Perfusion index

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

Intervention Type DIAGNOSTIC_TEST

serum lactate level

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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 .

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Samir Wahdan

Assistant Professor of Anesthesia, Pain management and Surgical ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr s wahdan, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo university , Cairo, Egypt

Locations

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Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-390-2020

Identifier Type: -

Identifier Source: org_study_id

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