Pressure Supporting Ventilation and EEG-guided Emergence for Free of Unwanted Complications

Pressure Supporting Ventilation and Electroencephalography-guided Extubation for Free of Unwanted compLications (PEACEFUL): a Randomised Controlled Trial

This study aims to assess whether pressure supporting ventilation and electroencephalogram (EEG)-guided emergence can reduce airway complications after thyroid surgery compared with conventional emergence. Patients will be randomly assigned to either pressure supporting ventilation and EEG-guided emergence group (intervention group) or conventional emergence group (control group). Co-primary outcomes are the incidence of emergence coughing and lowest percutaneous oxygen saturation (SpO2) after emergence. Secondary outcomes included severity of emergence cough, emergence time, blood pressure and heart rate during emergence, Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon post-anesthesia care unit (PACU) arrival, incidence of desaturation during PACU stay, hoarseness, sore throat during PACU stay, duration of PACU stay, surgeon satisfaction regarding emergence process, postoperative pain score, and patient satisfaction score regarding emergence process.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Surgery
• Intervention / Treatment: Procedure: PSV; Procedure: EEG-Guidance; Procedure: Spontaneous Respiration; Procedure: Intermittent Manual Assistance; Procedure: Obey Command

Detailed Description

Adult patients aged < 40 years scheduled to undergo thyroid surgery will be screened for eligibility. Patients will be randomly allocate to either the intervention group or control group.

• In the intervention group, pressure support ventilation will be applied from the start of subcutaneous suture until extubation. At the end of surgery, sevoflurane will be discontinued, and the attending anesthesiologist will perform tracheal extubation after observing the 'zipper opening' pattern on the EEG spectrogram, indicating the patient's recovery of consciousness. For safety reason, extubation will also be guided by the following processed EEG indices thresholds:

  1. 95% spectral edge frequency (SEF) ≥ 23
  2. Patient state index (PSI) ≥ 64
• In the control group, conventional full-awake extubation will be performed based on the routine practice of our institution. At the end of surgery, sevoflurane will be stopped, and the attending anesthesiologist will lead the emergence process, allowing the patient to breathe spontaneously and providing intermittent manual assistance if necessary. Extubation will be performed when the patient meets the following criteria: obeys commands such as eye-opening or hand-grip, tidal volume > 5 ml/kg, end-tidal carbon dioxide < 45 mmHg, spontaneous respiratory rate 10 to 20 breaths/min.

In both groups, the Oxygen Reserve Index (ORi) will be monitored. Blinded investigator will assess the incidence of emergence coughing and the lowest SpO2 after emergence.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Sun-Kyung Park; Phone Number: 82-2-2019-4601; Email: mayskpark@gmail.com
    • Principal Investigator: Young Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged under 40 years who are scheduled to undergo thyroid surgery.

Exclusion Criteria:

• Patients scheduled for radical neck dissection
• Patients scheduled for lymph node biopsy
• Patients with an anticipated difficult airway
• Patients experiencing difficulty during intubation
• Patients with a fasting time not meeting institutional policy
• Patients with a body mass index (BMI) greater than 30 kg/m²
• Patients with sleep apnea
• Pregnant or breastfeeding women
• Patients unable to communicate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Emergence group; Conventional full-awake extubation will be performed based on the routine practice of our institution. At the end of surgery, sevoflurane will be stopped, and the attending anesthesiologist will lead the emergence process, allowing the patient to breathe spontaneously and providing intermittent manual assistance if necessary. Extubation will be performed when the patient meets the following criteria: obeys commands such as eye-opening or hand-grip, tidal volume > 5 ml/kg, end-tidal carbon dioxide < 45 mmHg, spontaneous respiratory rate 10 to 20 breaths/min.	Procedure: Spontaneous Respiration; Extubation criteria include: Tidal volume > 5 ml/kg End-tidal carbon dioxide (ETCO2) < 45 mmHg Spontaneous respiratory rate (RR) 10 to 20 breaths/min; Procedure: Intermittent Manual Assistance; Volume-controlled mode during surgery, with intermittent manual assistance from the end of surgery until extubation.; Procedure: Obey Command; Extubation criteria include obeying commands (eye-opening or handgrip).
Experimental: Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group; Pressure support ventilation will be applied from the start of subcutaneous suture until extubation. At the end of surgery, sevoflurane will be discontinued, and the attending anesthesiologist will perform tracheal extubation after observing the 'zipper opening' pattern on the EEG spectrogram, indicating the patient's recovery of consciousness. For safety reason, extubation will also be guided by the following processed EEG indices thresholds: 95% spectral edge frequency (SEF) ≥ 23; Patient state index (PSI) ≥ 64	Procedure: PSV; Pressure support ventilation applied from the start of subcutaneous suture until extubation.; Procedure: EEG-Guidance; Extubation criteria based on EEG findings:Zipper opening pattern observed in the spectrogram 95% spectral edge frequency (SEF) ≥ 23 Patient state index (PSI) ≥ 64; Procedure: Spontaneous Respiration; Extubation criteria include: Tidal volume > 5 ml/kg End-tidal carbon dioxide (ETCO2) < 45 mmHg Spontaneous respiratory rate (RR) 10 to 20 breaths/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of emergence coughing	Incidence of emergence coughing (defined as coughing during the time period from sevoflurane off until 5 minutes after extubation)	During the time period from sevoflurane cessation until 5 minutes after extubation
Lowest SpO2 after emergence	Lowest SpO2 after emergence (defined as the lowest SpO2 value during the time period from sevoflurane off to post-anesthesia care unit (PACU) discharge)	During the time period from sevoflurane cessation until post-anesthesia care unit (PACU) discharge, an average of 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Emergence coughing	The severity of emergence coughing will be assessed using the modified 4-point Minogue scale, with grades assigned as follows: grade 1 (none), grade 2 (mild), grade 3 (moderate), or grade 4 (severe). A higher score indicates a more severe cough.	During the time period from sevoflurane cessation until 5 minutes after extubation.
Incidence and severity of coughing during PACU stay	Incidence and severity of coughing during PACU stay evaluated using a modified 4-point Minogue scale.	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Emergence time	Time from sevoflurane cessation until tracheal extubation (minutes)	During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes
Time to leave operating room	Time from sevoflurane cessation until leaving operating room	During the time period from sevoflurane cessation until leaving operating room, an average of 30 minutes
Blood pressure during emergence	systolic, diastolic, mean blood pressure (mmHg)	during the time period from sevoflurane off until 5 minutes after extubation
Heart rate during emergence	Heart rate (beats per minute)	during the time period from sevoflurane off until 5 minutes after extubation
Incidence of endotracheal tube biting	Biting of the endotracheal tube; The investigator will observe whether the patient bites the endotracheal tube or not.	During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes
Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon PACU arrival	The Richmond Agitation-Sedation Scale (range : +4 to -5)	RASS will be assessed at two time points; (1) immediately after tracheal extubation, and (2) immediately after PACU arrival
Incidence of desaturation during PACU stay	Incidence of desaturation	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Hoarseness	Patients will be specifically asked about the existence of a hoarse voice	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Incidence and severity of sore throat	Incidence and severity of pain or irritation of the throat.	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Duration of PACU stay	Duration of PACU stay (minutes)	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed	Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed (0: totally unsatisfied, 10: totally satisfied)	Immediately after the transfer of the patient from operating room to PACU
Incidence of awareness with recall	Patients will be specifically asked whether they experienced intraoperative consciousness, explicit recall of intraoperative events, or the emergence process.	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Pain score during PACU stay	pain score assessed by numeric rating scale; from 0 (no pain) to 10 (worst pain)	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Patient satisfaction score regarding emergence process	0: totally unsatisfied, 10: totally satisfied	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Incidence of Postoperative hematoma	hematoma formation	After operation, through the hospitalization, an average of 3 days.
Incidence of wound dehiscence	dehiscence of the surgical wound	After operation, through the hospitalization, an average of 3 days.
reoperation	reoperation of thyroid surgery	After operation, through the hospitalization, an average of 3 days.
Oxygen Reserve Index	Index of the patient's oxygen reserve, with a unit-less scale between 0.00 and 1.00.	During the period from sevoflurane cessation until PACU discharge, an average of 1 hour
Hypoventilation after extubation (RR <8/min)	Hypoventilation defined as Respiratory Rate <8/min	During the time period from PACU admission until PACU discharge, an average of 40 minutes

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Publications and helpful links

General Publications

• Purdon PL, Pierce ET, Mukamel EA, Prerau MJ, Walsh JL, Wong KF, Salazar-Gomez AF, Harrell PG, Sampson AL, Cimenser A, Ching S, Kopell NJ, Tavares-Stoeckel C, Habeeb K, Merhar R, Brown EN. Electroencephalogram signatures of loss and recovery of consciousness from propofol. Proc Natl Acad Sci U S A. 2013 Mar 19;110(12):E1142-51. doi: 10.1073/pnas.1221180110. Epub 2013 Mar 4.
• Difficult Airway Society Extubation Guidelines Group; Popat M, Mitchell V, Dravid R, Patel A, Swampillai C, Higgs A. Difficult Airway Society Guidelines for the management of tracheal extubation. Anaesthesia. 2012 Mar;67(3):318-40. doi: 10.1111/j.1365-2044.2012.07075.x.
• Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, Kim W. Pressure Support versus Spontaneous Ventilation during Anesthetic Emergence-Effect on Postoperative Atelectasis: A Randomized Controlled Trial. Anesthesiology. 2021 Dec 1;135(6):1004-1014. doi: 10.1097/ALN.0000000000003997.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 3-2023-0338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No