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

NCT04991220 | Unknown DMC

• 1 other identifier: 2106-029-1232
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension on Induction

Keywords

Hypovolemia; Pulse Wave Analysis; Hypotension; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Systolic blood pressure

  from entering operating room to just before intubation

• Diastolic blood pressure

  from entering operating room to just before intubation

• Heart rate

  from entering operating room to just before intubation

• Perfusion index

  from entering operating room to just before intubation

• Pulse oximetry plethysmographic waveform; ΔPOP

  from the administration of anesthetic agent to just before intubation

Study Arms (1)

preoxygenation

EXPERIMENTAL

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

Procedure: Preoxygenation

Interventions

Preoxygenation PROCEDURE

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

preoxygenation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing elective surgery under general anesthesia

You may not qualify if:

• (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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• GEMSKOREA: collaborator

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Related Publications (14)

• 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. doi: 10.1097/00000542-199412000-00013.

  PMID: 7992907 BACKGROUND

• 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.

  PMID: 20236098 BACKGROUND

• 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.

  PMID: 8214693 BACKGROUND

• Berthoud M, Read DH, Norman J. Pre-oxygenation--how long? Anaesthesia. 1983 Feb;38(2):96-102. doi: 10.1111/j.1365-2044.1983.tb13925.x.

  PMID: 6402951 BACKGROUND

• 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. doi: 10.1097/00000542-199909000-00009.

  PMID: 10485768 BACKGROUND

• Bagci S, Muller N, Muller 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.

  PMID: 23132180 BACKGROUND

• 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.

  PMID: 26242233 BACKGROUND

• 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.

  PMID: 25573314 BACKGROUND

• 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.

  PMID: 24904427 BACKGROUND

• 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. No abstract available.

  PMID: 30412709 BACKGROUND

• 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. doi: 10.1097/00000539-200208000-00003.

  PMID: 12145033 BACKGROUND

• 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. No abstract available.

  PMID: 25980576 BACKGROUND

• 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. doi: 10.1023/a:1007431305610.

  PMID: 9676861 BACKGROUND

• Kim YJ, Seo JH, Lee HC, Kim HS. Pleth variability index during preoxygenation could predict anesthesia-induced hypotension: A prospective, observational study. J Clin Anesth. 2023 Nov;90:111236. doi: 10.1016/j.jclinane.2023.111236. Epub 2023 Aug 26.

  PMID: 37639751 DERIVED

MeSH Terms

Conditions

Hypovolemia; Hypotension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hee Soo Kim, M.D., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoon Jung Kim

CONTACT

+82-10-9088-6452; imovax4@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 5, 2021
• Study Start: August 30, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)