Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension

Hypotension on Induction Clinical Trial

Official title:

Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension During Induction of Anesthesia in Surgical Patients; Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04991220
• Other study ID #: 2106-029-1232
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Seoul National University Hospital
• Contact: Yoon Jung Kim
• Phone: +82-10-9088-6452
• Email: imovax4[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether the change in pleth variation index (PVI) according to preoxygenation can predict hypotension during anesthesia induction.

Description:

In patients with hypovolemia or dehydration, pulse pressure variation can be increased by spontaneous forced inspiratory breathing. PVI is a noninvasive method of indicator of fluid responsiveness like purse pressure variation. We expected that the amount of change in PVI between at the time of entering operating room and after preoxygenation with forced inspiration method could be different depending on the patient's volume status. After entering operating room, monitoring devices, anesthesia depth sensor, and Radical-7® Pulse CO-Oximeter® are attached. Patients rest for 5 minutes, and then baseline systolic blood pressure, diastolic blood pressure, mean blood pressure, and heart rate are collected every 1-minute. Pleth variability index (PVI), perfusion index (PI) are also measured continuously. For pre-oxygenation of anesthesia, take 8 deep breaths at flow 10 l/min of 100% oxygen for 1 minute with maximally forced inspiration. After that, for 2 minutes, patients breathe as usual while maintaining oxygen supply. until tracheal intubation or laryngeal mask insertion. Anesthesia is induced with target concentration infusion of 4.0 ng/ml of remifentanil and 4.0 ug/ml of propofol. When the patient loses consciousness, rocuronium 1.0 mg/kg is administrated and endotracheal tube or laryngeal mask is inserted 2 minutes after. PVI, PI, blood pressure, and heart rate are measured until tracheal intubation or laryngeal mask insertion. Anesthesia induction-related hypotension is defined as a decrease in mean arterial pressure below 60 mmHg at any timepoint from baseline parameter collection to until airway device insertion. The parameters are analyzed by comparing between groups with and without anesthesia induction-related hypotension.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing elective surgery under general anesthesia

Exclusion Criteria:

• (1) American Society of Anesthesiologists (ASA) physical status classification III or higher (2) Patients with cognitive impairment who are unable to follow instructions (3) Patients with pulmonary dysfunction (4) Other patients who are judged inappropriate to the experiment by the researcher

Related Conditions & MeSH terms

• Hypotension
• Hypotension on Induction

Intervention

Procedure:
• Preoxygenation
Taking 8 deep breaths at 10 l/min of 100% oxygen for 1 minute with forced inspiration for pre-oxygenation

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul	Jongro Gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	GEMSKOREA

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

Bagci S, Müller N, Müller A, Heydweiller A, Bartmann P, Franz AR. A pilot study of the pleth variability index as an indicator of volume-responsive hypotension in newborn infants during surgery. J Anesth. 2013 Apr;27(2):192-8. doi: 10.1007/s00540-012-1511-6. Epub 2012 Nov 7. — View Citation

Baraka AS, Taha SK, Aouad MT, El-Khatib MF, Kawkabani NI. Preoxygenation: comparison of maximal breathing and tidal volume breathing techniques. Anesthesiology. 1999 Sep;91(3):612-6. — View Citation

Berthoud M, Read DH, Norman J. Pre-oxygenation--how long? Anaesthesia. 1983 Feb;38(2):96-102. — View Citation

Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation. Propofol/fentanyl interaction. Anesthesiology. 1994 Dec;81(6):1384-93. — View Citation

Chu H, Wang Y, Sun Y, Wang G. Accuracy of pleth variability index to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis. J Clin Monit Comput. 2016 Jun;30(3):265-74. doi: 10.1007/s10877-015-9742-3. Epub 2015 Aug 5. Review. — View Citation

Hug CC Jr, McLeskey CH, Nahrwold ML, Roizen MF, Stanley TH, Thisted RA, Walawander CA, White PF, Apfelbaum JL, Grasela TH, et al. Hemodynamic effects of propofol: data from over 25,000 patients. Anesth Analg. 1993 Oct;77(4 Suppl):S21-9. — View Citation

Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):e51-e156. doi: 10.1016/j.jacc.2018.10.044. Epub 2018 Nov 6. Erratum in: J Am Coll Cardiol. 2019 Aug 20;74(7):1016-1018. — View Citation

Larsen SL, Lyngeraa TS, Maschmann CP, Van Lieshout JJ, Pott FC. Cardiovascular consequence of reclining vs. sitting beach-chair body position for induction of anesthesia. Front Physiol. 2014 May 19;5:187. doi: 10.3389/fphys.2014.00187. eCollection 2014. — View Citation

Reich DL, Bennett-Guerrero E, Bodian CA, Hossain S, Winfree W, Krol M. Intraoperative tachycardia and hypertension are independently associated with adverse outcome in noncardiac surgery of long duration. Anesth Analg. 2002 Aug;95(2):273-7, table of contents. — View Citation

Rheineck-Leyssius AT, Kalkman CJ. Influence of pulse oximeter settings on the frequency of alarms and detection of hypoxemia: Theoretical effects of artifact rejection, alarm delay, averaging, median filtering or a lower setting of the alarm limit. J Clin Monit Comput. 1998 Apr;14(3):151-6. — View Citation

Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. — View Citation

Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10. — View Citation

Wu Y, Zhang F, Sun K, Yu L, Zhang H, Yan M. [Evaluation of pleth variability index for predicting hypotension during induction of anesthesia in surgical patients]. Zhonghua Yi Xue Za Zhi. 2014 Nov 4;94(40):3167-70. Chinese. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension during anesthesia induction	When mean blood pressure decreases to less than 60 mmHg at least once from the administration of anesthetic agent to just before intubation	from start of anesthesia induction to just before intubation
Secondary	Systolic blood pressure	systolic blood pressure with non-invasive blood pressure at 1-minute intervals.	from entering operating room to just before intubation
Secondary	Diastolic blood pressure	diastolic blood pressure with non-invasive blood pressure at 1-minute intervals.	from entering operating room to just before intubation
Secondary	Heart rate	heart rate which was measured continuously.	from entering operating room to just before intubation
Secondary	Perfusion index	Perfusion index from Radical-7® Pulse CO-Oximeter® which was measured continously.	from entering operating room to just before intubation
Secondary	Pulse oximetry plethysmographic waveform; ?POP	Respiratory variations in the pulse oximetry plethysmographic waveform amplitude	from the administration of anesthetic agent to just before intubation
Secondary	Pleth Variability Index (PVi®)	the relative variability of the pleth waveform (perfusion index) detected from a Radical-7® Pulse CO-Oximeter®	from entering operating room to just before intubation
Secondary	Saturation of percutaneous oxygen	from a Radical-7® Pulse CO-Oximeter®	from entering operating room to just before intubation