AnesthesiaNCT05189431
Peripheral Perfusion Index During Induction of Anaesthesia
An observational study of Anesthesia, run by Jakob Højlund at 1 site in Denmark.
Trial summary
We wish to study the feasibilty of using the peripheral perfusion index as a supplementary monitor during induction of general anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- How many people
- 111 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2018to 30 Nov 2019
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of general populace for surgery under general anesthesia
Who may be able to join
- Scheduled surgery under general anesthesia
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Power of Peripheral Perfusion Index During Induction of Aneasthesia
We wish to study the feasibilty of using the peripheral perfusion index as a supplementary monitor during induction of general anesthesia
Read the detailed description
Haemodynamic monitoring during general anaesthesia (GA) traditionally relies on simple and readily available parameters such as blood pressure and heart rate. Most patients will only have intermittent non-invasive monitoring of blood pressure. During the induction phase an abrupt reduction in blood pressure is often seen, with possible deleterious consequences for organ perfusion [1,2]. The availability of continuous monitoring of systemic haemodynamics is limited by cost and scarcity of equipment and personnel.
The peripheral perfusion index (PPI) is obtained non-invasively by photoplethysmography - ubiquitously present in the perioperative setting [3,4]. The PPI is a simple ratio describing the proportion of pulsatile to non-pulsatile signal attenuation. No specialized equipment is needed as the PPI is inherent to photoplethysmography already ubiquitous during GA, although not all pulse-oxymeters are set up to display PPI. The PPI in awake patients is dominated by sympathetic tone [4] creating a highly positively skewed distribution [3]. Conversely, during GA cardiac stroke volume (SV) becomes the major determinant of PPI [5,6]. Very little evidence exists regarding the efficacy of PPI as a monitor during the induction of GA. Presumably, the net effect will be a composite of two opposing mechanisms: Sympatholysis increasing PPI, with decreased SV/CO causing the opposite effect.
The present study was designed to explore the clinical utility of the non-invasively obtained peripheral perfusion index to detect cardiovascular compromise during induction of general anaesthesia. We hypothesized that during induction of GA changes in systemic haemodynamics in the form of mean arterial pressure (MAP) and cardiac stroke volume (SV) and -output (CO) during GA would be reflected in the PPI, albeit in a complex manner. Thus, a predominant vasodilatory response might be differentiated from a response dominated by decreased CO.
- Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vásquez SM, et al. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death. Anesthesiology [Internet]. 2018 [cited 2018 Nov 30];128:317-27. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29189290
- Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, et al. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery. Anesthesiology [Internet]. 2017 [cited 2018 Nov 30];126:47-65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27792044
- Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med [Internet]. 2002 [cited 2018 Jan 11];30:1210-3. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12072670
- Reisner A, Shaltis PA, McCombie D, Asada HH. Utility of the photoplethysmogram in circulatory monitoring. Anesthesiology. 2008;108:950-8.
- Conditions
- Anesthesia
- Keywords
- monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in systemic hemodynamics at 2 minutes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Jul 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- 111 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jakob Højlund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakob Højlund, Hvidovre University Hospital
- Investigators
- Jakob Højlund, MD, Principal investigator, Dept. Anesthesiology, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189431
- Sponsor's protocol ID
- H-19016524
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Power of Peripheral Perfusion Index During Induction of Aneasthesia
- ClinicalTrials.gov ID
- NCT05189431
- Acronym / sponsor ID
- H-19016524
- Conditions
- Anesthesia
- Keywords
- monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Jakob HøjlundUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 12 Jan 2022 (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.
We wish to study the feasibilty of using the peripheral perfusion index as a supplementary monitor during induction of general anesthesia
Detailed description
Haemodynamic monitoring during general anaesthesia (GA) traditionally relies on simple and readily available parameters such as blood pressure and heart rate. Most patients will only have intermittent non-invasive monitoring of blood pressure. During the induction phase an abrupt reduction in blood pressure is often seen, with possible deleterious consequences for organ perfusion [1,2]. The availability of continuous monitoring of systemic haemodynamics is limited by cost and scarcity of equipment and personnel.
The peripheral perfusion index (PPI) is obtained non-invasively by photoplethysmography - ubiquitously present in the perioperative setting [3,4]. The PPI is a simple ratio describing the proportion of pulsatile to non-pulsatile signal attenuation. No specialized equipment is needed as the PPI is inherent to photoplethysmography already ubiquitous during GA, although not all pulse-oxymeters are set up to display PPI. The PPI in awake patients is dominated by sympathetic tone [4] creating a highly positively skewed distribution [3]. Conversely, during GA cardiac stroke volume (SV) becomes the major determinant of PPI [5,6]. Very little evidence exists regarding the efficacy of PPI as a monitor during the induction of GA. Presumably, the net effect will be a composite of two opposing mechanisms: Sympatholysis increasing PPI, with decreased SV/CO causing the opposite effect.
The present study was designed to explore the clinical utility of the non-invasively obtained peripheral perfusion index to detect cardiovascular compromise during induction of general anaesthesia. We hypothesized that during induction of GA changes in systemic haemodynamics in the form of mean arterial pressure (MAP) and cardiac stroke volume (SV) and -output (CO) during GA would be reflected in the PPI, albeit in a complex manner. Thus, a predominant vasodilatory response might be differentiated from a response dominated by decreased CO.
- Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vásquez SM, et al. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death. Anesthesiology [Internet]. 2018 [cited 2018 Nov 30];128:317-27. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29189290
- Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, et al. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery. Anesthesiology [Internet]. 2017 [cited 2018 Nov 30];126:47-65. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27792044
- Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med [Internet]. 2002 [cited 2018 Jan 11];30:1210-3. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12072670
- Reisner A, Shaltis PA, McCombie D, Asada HH. Utility of the photoplethysmogram in circulatory monitoring. Anesthesiology. 2008;108:950-8.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of general populace for surgery under general anesthesia
Key inclusion criteria (1 listed)
- Scheduled surgery under general anesthesia
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in systemic hemodynamics at 2 minutes
Time frame: 1 day
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 12 Jan 2022.
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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.
Jakob Højlund, MD principal investigator
Dept. Anesthesiology, Hvidovre University Hospital
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 Anesthesia, run by Jakob Højlund at 1 site in Denmark.
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 1 inclusion and 1 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 12 Jan 2022. 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 Denmark. 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?
Changes in systemic hemodynamics at 2 minutes (time frame: 1 day). 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 12 Jan 2022.