Predictor of Postoperative Complications After Lengthy Surgical Procedures

Peripheral Perfusion Index Clinical Trial

Official title:

Peripheral Perfusion Index Versus Serum Lactate Levels as Predictor of Postoperative Complications and Prolonged ICU Stay After Lengthy Surgical Procedures: a Prospective Observational Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04680663
• Other study ID #: MS-390-2020
• Status: Enrolling by invitation
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: December 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 102
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

• 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-III

• Patients scheduled for elective surgery under general anaesthesia .

• Exclusion criteria

• Refused to participate .

• ASA physical status of IV .

• 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 .

• Pregnancyor emergency surgery .

• shortening of the planned surgical time to be less than 120 minutes due to a surgical factor for example irrespectability or other causes .

Related Conditions & MeSH terms

• Peripheral Perfusion Index
• Postoperative Complications

Intervention

Diagnostic Test:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum lactate level	at end of surgery as early predictor of postoperative complications .	UP TO 1 HOURE
Primary	Peripheral perfusion index	at end of surgery as early predictor of postoperative complications .	UP TO 1 HOURE
Secondary	Length of ICU stay	BY DAY	UP TO 30 DAY
Secondary	hospital stay length	BY DAY	UP TO 30 DAY
Secondary	duration of surgical time	MIN	UP TO 24 HOURE