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

NCT06165562 | Recruiting

• 1 other identifier: 3-2023-0338
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• Severity of Emergence coughing

  During the time period from sevoflurane cessation until 5 minutes after extubation.

• Incidence and severity of coughing during PACU stay

  During the time period from PACU admission until PACU discharge, an average of 40 minutes

• Emergence time

  During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes

• Time to leave operating room

  During the time period from sevoflurane cessation until leaving operating room, an average of 30 minutes

• Blood pressure during emergence

  during the time period from sevoflurane off until 5 minutes after extubation

Study Arms (2)

Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group

EXPERIMENTAL

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

Procedure: PSV; Procedure: EEG-Guidance; Procedure: Spontaneous Respiration

Conventional Emergence group

ACTIVE COMPARATOR

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: Intermittent Manual Assistance; Procedure: Obey Command; Procedure: Spontaneous Respiration

Interventions

PSV PROCEDURE

Pressure support ventilation applied from the start of subcutaneous suture until extubation.

Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group

Intermittent Manual Assistance PROCEDURE

Volume-controlled mode during surgery, with intermittent manual assistance from the end of surgery until extubation.

Conventional Emergence group

EEG-Guidance PROCEDURE

Extubation criteria based on EEG findings:Zipper opening pattern observed in the spectrogram 95% spectral edge frequency (SEF) ≥ 23 Patient state index (PSI) ≥ 64

Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group

Obey Command PROCEDURE

Extubation criteria include obeying commands (eye-opening or handgrip).

Conventional Emergence group

Spontaneous Respiration PROCEDURE

Extubation criteria include: Tidal volume \> 5 ml/kg End-tidal carbon dioxide (ETCO2) \< 45 mmHg Spontaneous respiratory rate (RR) 10 to 20 breaths/min

Conventional Emergence group; Pressure Supporting Ventilation (PSV) and EEG-guided Emergence group

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 22321104 BACKGROUND

• 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.

  PMID: 23487781 BACKGROUND

• 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.

  PMID: 34610099 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, medical staff responsible for measuring outcome variables, surgeons, and nurses in the recovery room and wards will be blinded. This blinding approach ensures that both medical staff and patients remain unaware of the assigned group throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associcate Professor

Model Details: Prospective, single-blinded, parallel-group, randomized clinical study

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 11, 2023
• Study Start: January 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)