Clinical trial NCT06165562: Pressure Supporting Ventilation and EEG-guided Emergence for Free of Unwanted Complications
Official title: Pressure Supporting Ventilation and Electroencephalography-guided Extubation for Free of Unwanted compLications (PEACEFUL): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Surgery
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-blinded, parallel-group, randomized clinical study
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of emergence coughing
timeFrame: During the time period from sevoflurane cessation until 5 minutes after extubation
measure: Lowest SpO2 after emergence
timeFrame: During the time period from sevoflurane cessation until post-anesthesia care unit (PACU) discharge, an average of 1 hour
Secondary outcomes:
measure: Severity of Emergence coughing
timeFrame: During the time period from sevoflurane cessation until 5 minutes after extubation.
measure: Incidence and severity of coughing during PACU stay
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Emergence time
timeFrame: During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes
measure: Time to leave operating room
timeFrame: During the time period from sevoflurane cessation until leaving operating room, an average of 30 minutes
measure: Blood pressure during emergence
timeFrame: during the time period from sevoflurane off until 5 minutes after extubation
measure: Heart rate during emergence
timeFrame: during the time period from sevoflurane off until 5 minutes after extubation
measure: Incidence of endotracheal tube biting
timeFrame: During the time period from sevoflurane cessation until tracheal extubation, an average of 20 minutes
measure: Hypoventilation after extubation (RR <8/min)
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon PACU arrival
timeFrame: RASS will be assessed at two time points; (1) immediately after tracheal extubation, and (2) immediately after PACU arrival
measure: Incidence of desaturation during PACU stay
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Hoarseness
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Incidence and severity of sore throat
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Duration of PACU stay
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed
timeFrame: Immediately after the transfer of the patient from operating room to PACU
measure: Incidence of awareness with recall
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Pain score during PACU stay
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Patient satisfaction score regarding emergence process
timeFrame: During the time period from PACU admission until PACU discharge, an average of 40 minutes
measure: Incidence of Postoperative hematoma
timeFrame: After operation, through the hospitalization, an average of 3 days.
measure: Incidence of wound dehiscence
timeFrame: After operation, through the hospitalization, an average of 3 days.
measure: reoperation
timeFrame: After operation, through the hospitalization, an average of 3 days.
measure: Oxygen Reserve Index
timeFrame: During the period from sevoflurane cessation until PACU discharge, an average of 1 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.