SPI Value Relevance in Clinical Practice

NCT02074475 | Completed

• 1 other identifier: JH2013-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Primary endpoint: Defining The optimal target range for Surgical Pleth index. Surgical Pleth Index (SPI, formerly used SSI = Surgical Stress Index) is a novel multivariate index, which is based on the sum of the normalized pulse beat interval (PBI) and the photoplethysmography. SPI indicates the balance between intensity of surgical stimulation and the level of anti-nociception (opioid analgesia and neural blockade). This study is a Spin off from a larger Adequacy of Anaesthesia study and aims on finding the most appropriate target range for SPI in order to avoid signs of inadequate anaesthesia. Patients are treated without monitoring adequacy of anaesthesia thus the values are collected blinded and analyzed afterwards in accordance of signs for inadequate anaesthesia. The study population will be 150 patients.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• optimal maximum limit for SPI

  SPI -value at a predefined criteria for signs of anaesthesia.

  1 day

Secondary Outcomes (1)

• Optimal lower limit for SPI

  1 day

Study Arms (1)

Control group

The control group of three sites for larger Adequacy of Anaesthesia study. Total 150 patients

Other: Control group

Interventions

Control group OTHER

A group of no Monitoring patients from larger AoA study with no adequacy of anaesthesia monitoring

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients assessed for operation lasting more than two hours and requiring intubation.

You may qualify if:

• Ability to provide written informed consent
• Age 18-80 years of age
• Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube

You may not qualify if:

• Any subject that meets the definition of vulnerable subject as defined in ISO 14155:2011o Per ISO 14155:2011, a vulnerable subject is defined as an individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate
• Any subject with a cardiac pacemaker
• Any subject with atrial fibrillation at the time of obtaining the baseline values
• Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
• Any subject who needs invasive blood pressure measurement
• Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline:
• o Mean blood pressure below 60 mmHg or above 100 mmHg o HR below 45 /min or above 100/min
• Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
• Any subject having surgery that requires prone position
• Any subject with very high body mass index (\>35) because of incompatibility with the target controlled anesthesia models used
• Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
• Any subject with laryngeal mask airway
• Any subject who requires neuromuscular blocking agent infusion
• Any subject who is going to have major surgery with a high risk of extensive blood loss
• Any subject with known chronic use of opioids

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jarkko Harju, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: February 28, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

FI (1)