Peripheral Perfusion IndexcomplicationNCT04680663
Predictor of Postoperative Complications After Lengthy Noncardiac Surgery
An observational study of Peripheral Perfusion Index, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Perfusion Index
- What is being tested?
- Peripheral Perfusion index and serum lactate level
- How many people
- 235 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 10 Jun 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: This study will be designed to recruit patients scheduled for elective surgery with duration > 120 minutes under general anaesthesia
Who may be able to join
- 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 .
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Peripheral Perfusion index, serum lactate level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Perfusion indexDiagnostic 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 levelDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Non complications group | where the non-complicated patients is the patients running the normal postoperative course of surgery and without any need for intervention Receives: Diagnostic Test: Peripheral Perfusion index; Diagnostic Test: serum lactate level | |
| complications group | any deviation from the normal post-operative course Receives: Diagnostic Test: Peripheral Perfusion index; Diagnostic Test: serum lactate level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral perfusion index
at end of surgery as early predictor of postoperative complications .
Measured: up to 48 hours
serum lactate level
at end of surgery as early predictor of postoperative complications .
Measured: up do 48 hours
Secondary outcomes (5)
serum lactate level
at end of surgery as early predictor of postoperative complications .
Measured: UP TO 30 day
Peripheral perfusion index
at end of surgery as predictor seversity of postoperative complications .
Measured: UP TO 30 DAY
Postoperative complications
the Clavien-Dindo classification system Grade I complications Grade II complications Grade III complications Grade IV complications
Measured: up to 30 day
hemodynamic change
mean arterial blood pressure
Measured: up do 48 hours
heart rate
hemodynamic change
Measured: up do 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start15 Mar 2021
- Primary completion12 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Perfusion IndexStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- Amr s wahdan, MD, Principal investigator, Cairo university , Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680663
- Sponsor's protocol ID
- MS-390-2020
- Acronym
- complication
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2020
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04680663
- Acronym / sponsor ID
- complication / MS-390-2020
- Conditions
- Peripheral Perfusion Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 12 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non complications group | – | Diagnostic Test: Peripheral Perfusion index, Diagnostic Test: serum lactate levelwhere the non-complicated patients is the patients running the normal postoperative course of surgery and without any need for intervention |
| complications group | – | Diagnostic Test: Peripheral Perfusion index, Diagnostic Test: serum lactate levelany deviation from the normal post-operative course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will be designed to recruit patients scheduled for elective surgery with duration > 120 minutes under general anaesthesia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Perfusion indexPeripheral Perfusion index is the ratio between pulsatile blood flow to non pulsatile blood flow or static blood in the peripheral tissue | Diagnostic test | Non complications group, complications group |
| serum lactate levelBlood lactate (product of metabolism) level is maintained by a cycle of continuous production and metabolism allowing it to be kept within normal values | Diagnostic test | Non complications group, complications group |
Primary outcome
Peripheral perfusion index
Time frame: up to 48 hours
at end of surgery as early predictor of postoperative complications .
serum lactate level
Time frame: up do 48 hours
at end of surgery as early predictor of postoperative complications .
5 secondary outcomes
serum lactate level
Time frame: UP TO 30 day
Peripheral perfusion index
Time frame: UP TO 30 DAY
Postoperative complications
Time frame: up to 30 day
hemodynamic change
Time frame: up do 48 hours
heart rate
Time frame: up do 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr s wahdan, MD principal investigator
Cairo university , Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Perfusion Index, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral perfusion index (time frame: up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.