Surgical Pleth Index: Predicting the Optimal Timing for Tracheal Intubation During General Anesthesia

Trachea Intubation Clinical Trial

Official title:

Dose Surgical Pleth Index Play a Role to Predict Optimal Timing for Tracheal Intubation During Anesthetic Induction?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608240
• Other study ID #: SPI V 1.0
• Status: Recruiting
• Start date: September 30, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2021
• Source: Fudan University
• Contact: Jun Zhang, PhD
• Phone: 86-21-64175590
• Email: snapzhang[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical pleth index (SPI) has been widely investigated in assessing the nociceptive level, and tracheal intubation is a noxious stimulus during the induction of anesthesia. This study aims to evaluate the ability of SPI to predict hemodynamic reactivity after tracheal intubation, and find the target value of SPI to guide the optimal timing for tracheal intubation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: November 30, 2021
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trachea Intubation
• Tracheal Diseases

Locations

Country	Name	City	State
China	Department of Anesthesiology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

Bergmann I, Göhner 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. — View Citation

Huiku M, Uutela K, van Gils M, Korhonen I, Kymäläinen M, Meriläinen P, Paloheimo M, Rantanen M, Takala P, Viertiö-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. Epub 2007 Feb 28. — View Citation

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. Epub 2007 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ability of SPI to predict hemodynamic reactivity after tracheal intubation in general population	The area under receiver-operating characteristic curve (AUC) of SPI	within 2 minutes after trachea intubation
Primary	ability of SPI to predict hemodynamic reactivity after tracheal intubation in female	The area under receiver-operating characteristic curve (AUC) of SPI	within 2 minutes after trachea intubation
Primary	ability of SPI to predict hemodynamic reactivity after tracheal intubation in male	The area under receiver-operating characteristic curve (AUC) of SPI	within 2 minutes after trachea intubation
Secondary	influence factors of hemodynamic reactivity	using logistic regression model	within 2 minutes after trachea intubation
Secondary	Cardiovascular stress level	delta rate pressure product (?RPP) between different ranges of SPI	within 2 minutes after trachea intubation