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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05189431
Other study ID # H-19016524
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date November 30, 2019

Study information

Verified date December 2021
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We wish to study the feasibilty of using the peripheral perfusion index as a supplementary monitor during induction of general anesthesia


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.


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled surgery under general anesthesia Exclusion Criteria: - Refusal to participate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre Capital Region

Sponsors (1)

Lead Sponsor Collaborator
Jakob Højlund

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in systemic hemodynamics at 2 minutes 1 day
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