- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04608240
Surgical Pleth Index: Predicting the Optimal Timing for Tracheal Intubation During General Anesthesia
Dose Surgical Pleth Index Play a Role to Predict Optimal Timing for Tracheal Intubation During Anesthetic Induction?
Study Overview
Status
Conditions
Detailed Description
The surgical pleth index (SPI)monitored by a oxygen saturation (Spo2) probe, is a dimensionless score which is based on the photoplethysmographic analysis of the pulse wave and the heartbeat interval. SPI score monitored during surgery is the indicator that may reflect a patient's autonomic response to certain noxious stimulus and is correlated to his/her nociception level. Once noxious stimulus occur, sympathetically-mediated vasoconstriction and cardiac autonomic tone increasing can be reflected by SPI. Several studies have since investigated the potential benefits of SPI-guided anesthesia, such as SPI could reduce the intraoperative opioid consumption and facilitate extubation after surgery.Jain N et al. found that the need for postoperative analgesics decreased although fentanyl consumption increased, when SPI guided opioid use Intraoperatively . The level of SPI was also reported to be able to predict postoperative pain, which could guide clinical use of opioids and improve patient postoperative satisfaction.
Recent studies on SPI mainly focus on the maintenance period of anesthesia and postoperative analgesia, and there is few studies on the application of SPI in anesthesia induction period. Hemodynamic stability in induction period has always been the technical key point that anesthesiologists pay attention to, especially for patients with cardiovascular and cerebrovascular diseases, maintaining hemodynamic stability is particularly important. Endotracheal intubation is a common procedure during general anesthesia. The hemodynamic fluctuation caused by intubation stimulation is usually caused by the premature timing of intubation.
At present, the timing of intubation is much depended on the clinical experience of an anesthesiologist, such as according to the degree of blood pressure, heart rate decline or predicted onset of propofol,opioid and neuromascular blocker. This study aims to explore whether the SPI can be used in quantitative prediction of intubation timing or prediction the hemodynamic reactivity after intubation, and to investigate the influence of age and gender on SPI value.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Department of Anesthesiology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anesthesiology physical status (ASA) 1-2
- Patients aged 18-80 years undergoing non-emergency anesthesia
Exclusion Criteria:
- age <18 years
- severe peripheral or cardiac neuropathy
- significant arrhythmia (i.e. atrial fibrillation or atrioventricular block)
- pacemaker
- neurovascular diseases
- uncontrolled hypertension
- treatment with vasoactive medication during the induction of anesthesia
- any intraoperative treatment with beta receptor blockers, clonidine, beta receptor agonists, or any other drug suspected to interact with the sympathovagal balance
- predicted difficult ventilation
- chronic pain requiring long-term analgesics
- addictive to opioids.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ability of SPI to predict hemodynamic reactivity after tracheal intubation in general population
Time Frame: within 2 minutes after trachea intubation
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The area under receiver-operating characteristic curve (AUC) of SPI
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within 2 minutes after trachea intubation
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ability of SPI to predict hemodynamic reactivity after tracheal intubation in female
Time Frame: within 2 minutes after trachea intubation
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The area under receiver-operating characteristic curve (AUC) of SPI
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within 2 minutes after trachea intubation
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ability of SPI to predict hemodynamic reactivity after tracheal intubation in male
Time Frame: within 2 minutes after trachea intubation
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The area under receiver-operating characteristic curve (AUC) of SPI
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within 2 minutes after trachea intubation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
influence factors of hemodynamic reactivity
Time Frame: within 2 minutes after trachea intubation
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using logistic regression model
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within 2 minutes after trachea intubation
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Cardiovascular stress level
Time Frame: within 2 minutes after trachea intubation
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delta rate pressure product (ΔRPP) between different ranges of SPI
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within 2 minutes after trachea intubation
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
- Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress index in response to standardized pain stimuli during propofol-remifentanil infusion. Br J Anaesth. 2007 Sep;99(3):359-67. doi: 10.1093/bja/aem173. Epub 2007 Jul 3.
- Bergmann I, Gohner A, Crozier TA, Hesjedal B, Wiese CH, Popov AF, Bauer M, Hinz JM. Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia. Br J Anaesth. 2013 Apr;110(4):622-8. doi: 10.1093/bja/aes426. Epub 2012 Dec 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPI V 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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