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

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Thyroid Surgery

Treatments: Procedure: Spontaneous Respiration; Procedure: EEG-Guidance; Procedure: PSV; Procedure: Obey Command; Procedure: Intermittent Manual Assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT06165562

3-2023-0338

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 19 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Procedure: EEG-Guidance

Procedure: Spontaneous Respiration

Procedure: PSV

Conventional Emergence group

Active Comparator group

Description:

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.

Treatment:

Procedure: Spontaneous Respiration

Procedure: Intermittent Manual Assistance

Procedure: Obey Command