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Thyroid SurgeryNCT06165562

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

A study testing PSV, Intermittent Manual Assistance and EEG-Guidance in people with Thyroid Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 to 39 years
Conditions the study is for
Thyroid Surgery
What is being tested?
PSV, Intermittent Manual Assistance and EEG-Guidance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSouth Korea
Study dates
5 Jan 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients with sleep apnea
  • Pregnant or breastfeeding women
  • Patients unable to communicate

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Gangnam Severance Hospital

    Seoul

    Sun-Kyung Park, 82-2-2019-4601, mayskpark@gmail.com

    Young Song

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Thyroid Surgery
Being tested
PSV, Intermittent Manual Assistance, EEG-Guidance, Obey Command, Spontaneous Respiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PSVProcedure or surgery

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

  • Intermittent Manual AssistanceProcedure or surgery

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

  • EEG-GuidanceProcedure or surgery

    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 CommandProcedure or surgery

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

  • Spontaneous RespirationProcedure or surgery

    Extubation criteria include:

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

Study groups in NCT06165562
Study groupRoleWhat they receive
Pressure Supporting Ventilation (PSV) and EEG-guided Emergence groupExperimentalPressure 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
Receives: Procedure: PSV; Procedure: EEG-Guidance; Procedure: Spontaneous Respiration
Conventional Emergence groupActive comparatorConventional 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.
Receives: Procedure: Intermittent Manual Assistance; Procedure: Obey Command; Procedure: Spontaneous Respiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of emergence coughing

    Incidence of emergence coughing (defined as coughing during the time period from sevoflurane off until 5 minutes after extubation)

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

  2. 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)

    Measured: During the time period from sevoflurane cessation until post-anesthesia care unit (PACU) discharge, an average of 1 hour

Secondary outcomes (21)

  1. 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.

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

  2. Incidence and severity of coughing during PACU stay

    Incidence and severity of coughing during PACU stay evaluated using a modified 4-point Minogue scale.

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

  3. Emergence time

    Time from sevoflurane cessation until tracheal extubation (minutes)

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

  4. Time to leave operating room

    Time from sevoflurane cessation until leaving operating room

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

  5. Blood pressure during emergence

    systolic, diastolic, mean blood pressure (mmHg)

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

  6. Heart rate during emergence

    Heart rate (beats per minute)

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

  7. Incidence of endotracheal tube biting

    Biting of the endotracheal tube; The investigator will observe whether the patient bites the endotracheal tube or not.

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

  8. Hypoventilation after extubation (RR <8/min)

    Hypoventilation defined as Respiratory Rate <8/min

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

  9. Richmond Agitation-Sedation Scale (RASS) immediately after extubation and upon PACU arrival

    The Richmond Agitation-Sedation Scale (range : +4 to -5)

    Measured: RASS will be assessed at two time points; (1) immediately after tracheal extubation, and (2) immediately after PACU arrival

  10. Incidence of desaturation during PACU stay

    Incidence of desaturation

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

  11. Hoarseness

    Patients will be specifically asked about the existence of a hoarse voice

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

  12. Incidence and severity of sore throat

    Incidence and severity of pain or irritation of the throat.

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

  13. Duration of PACU stay

    Duration of PACU stay (minutes)

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

  14. Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed

    Surgeon satisfaction regarding emergence process encompassing smoothness/safety/speed (0: totally unsatisfied, 10: totally satisfied)

    Measured: Immediately after the transfer of the patient from operating room to PACU

  15. Incidence of awareness with recall

    Patients will be specifically asked whether they experienced intraoperative consciousness, explicit recall of intraoperative events, or the emergence process.

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

  16. Pain score during PACU stay

    pain score assessed by numeric rating scale; from 0 (no pain) to 10 (worst pain)

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

  17. Patient satisfaction score regarding emergence process

    0: totally unsatisfied, 10: totally satisfied

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

  18. Incidence of Postoperative hematoma

    hematoma formation

    Measured: After operation, through the hospitalization, an average of 3 days.

  19. Incidence of wound dehiscence

    dehiscence of the surgical wound

    Measured: After operation, through the hospitalization, an average of 3 days.

  20. reoperation

    reoperation of thyroid surgery

    Measured: After operation, through the hospitalization, an average of 3 days.

  21. Oxygen Reserve Index

    Index of the patient's oxygen reserve, with a unit-less scale between 0.00 and 1.00.

    Measured: During the period from sevoflurane cessation until PACU discharge, an average of 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start5 Jan 2024
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, single-blinded, parallel-group, randomized clinical study
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165562
Sponsor's protocol ID
3-2023-0338
Status last verified
Mar 2024
First submitted
16 Nov 2023
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22321104

  • 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.

    PubMed 23487781

  • 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.

    PubMed 34610099

Questions about this trial

What is this clinical trial studying?

A study testing PSV, Intermittent Manual Assistance and EEG-Guidance in people with Thyroid Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of emergence coughing (time frame: During the time period from sevoflurane cessation until 5 minutes after extubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06165562, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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