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

Thyroid Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165562
• Other study ID #: 3-2023-0338
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Surgery

Intervention

Procedure:
• PSV
Pressure support ventilation applied from the start of subcutaneous suture until extubation.
• Intermittent Manual Assistance
Volume-controlled mode during surgery, with intermittent manual assistance from the end of surgery until extubation.
• 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
• Obey Command
Extubation criteria include obeying commands (eye-opening or handgrip).
• 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

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure during emergence	systolic, diastolic, mean blood pressure (mmHg)	during the time period from sevoflurane off until 5 minutes after extubation
Secondary	Heart rate during emergence	Heart rate (beats per minute)	during the time period from sevoflurane off until 5 minutes after extubation
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of desaturation during PACU stay	Incidence of desaturation	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Secondary	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
Secondary	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
Secondary	Duration of PACU stay	Duration of PACU stay (minutes)	During the time period from PACU admission until PACU discharge, an average of 40 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of Postoperative hematoma	hematoma formation	After operation, through the hospitalization, an average of 3 days.
Secondary	Incidence of wound dehiscence	dehiscence of the surgical wound	After operation, through the hospitalization, an average of 3 days.
Secondary	reoperation	reoperation of thyroid surgery	After operation, through the hospitalization, an average of 3 days.
Secondary	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