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AnesthesiaNCT05189431

Peripheral Perfusion Index During Induction of Anaesthesia

An observational study of Anesthesia, run by Jakob Højlund at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Denmark1 site
  • Hvidovre University Hospital

    Hvidovre, Capital Region, 2720

Other trials in Denmark

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.

  1. 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
  2. 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
  3. 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
  4. 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.

  1. 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.

  1. First posted12 Jan 2022
  2. Study start1 Jul 2018
  3. Primary completion30 Nov 2019
  4. Study completion30 Nov 2019

Resources

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
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

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.

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