The Relationship Between the SPI and the Postop ED (SPI_ED)

July 24, 2018 updated by: Eugene Kim, Daegu Catholic University Medical Center

The Relationship Between the Surgical Pleth Index (SPI) and the Postoperative Emergence Delirium in Pediatric Patients After General Anesthesia

Surgical plethysmography index (SPI) is a device that can noninvasively monitor the balance between the nociception and ant-nociception using pulse photoplethysmographic amplitude (PPGA) and heart rate obtained through an oxygen saturation measuring device. SPI has recently been studied as a useful tool to monitor the stress response of patients due to surgery or anesthesia and to guide the appropriate use of analgesics/anesthetics. However, these SPI devices have been developed for adults and have not been studied in pediatric patients with relatively high heart rates, and no direct effects on post-operative arousal excitability have been reported.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients aged 2-7 years with an American Society of Anaesthesiologists physical status (ASA PS) of 1 or 2, who were planned to undergo ophthalmology surgery requiring general anesthesia.

Description

Inclusion Criteria:

  • Pediatric patients aged 2-7 years with an American Society of Anaesthesiologists physical status (ASA PS) of 1 or 2, who were planned to undergo ophthalmology surgery requiring general anesthesia.

Exclusion Criteria:

  • ASA PS 3 or 4
  • Presence of developmental delays or neurological diseases
  • History of allergies or contraindications to the use of ketamine (increased intracranial pressure, open-globe injury, or a psychiatric or seizure disorder)
  • treatment with beta-receptor blockers, beta-receptor agonists or any other drug suspected to interact with the sympathovagal balance
  • diseases with impairment of sensitivity (diabetes, polyneuropathy, peripheral arterial obstructive disease et etc)
  • pacemaker therapy
  • dermal diseases with the affection of the forearm/hand

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Analgesia monitoring
After anesthesia induction, all participants received standard anesthesia monitoring, SPI monitor (GE Healthcare, Helsinki, Finland) and bispectral index (BIS). BIS was kept between 40-60, whereas no specific target was determined for SPI. At the end of surgery, anesthesia was terminated and the patients were stimulated to wake up. After the participants were able to breathe spontaneously and obey verbal commands, extubation was carefully performed, and the monitoring of SPI was stopped.
Device: SPI monitor (GE Healthcare, Helsinki, Finland)
The SPI is derived from pulse rate and pulse wave amplitude measured with photoplethysmography, obtained from the CARESCAPE B650 monitor (GE Healthcare, Finland) with a scale from 1 to 100.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relationship between the SPI during emergence time and the peak emergence delirium score
Time Frame: Observation from approximately 1 hour after the end of operation
The SPI is attained from waveform finger plethysmography. It is expressed as a numerical index between 0 (total absence of discomfort) and 100 (high stress level) with an increase after noxious stimulation. We will investigate the relationship between the SPI during emergence period and the pediatric assessment of emergence delirium (PAED) score.
Observation from approximately 1 hour after the end of operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The sensitivity and specificity of the SPI in detecting the emergence delirium
Time Frame: Observation from approximately 1 hour after the end of operation
Receiver operating characteristics (ROC) curves and the associated areas under the curves (AUC) were computed to characterize the sensitivity and specificity of the SPI in detecting a pediatric emergence at different PAED scores.
Observation from approximately 1 hour after the end of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DCMC#2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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