Pressure Supporting Ventilation and EEG-guided Emergence for Free of Unwanted Complications
NCT ID: NCT06165562
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2024-01-05
2024-12-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Pressure Supporting Ventilation (PSV) and EEG-guided Emergence 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
PSV
Pressure support ventilation applied from the start of subcutaneous suture 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
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
Conventional Emergence 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.
Intermittent Manual Assistance
Volume-controlled mode during surgery, with intermittent manual assistance from the end of surgery until extubation.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
39 Years
ALL
No
Sponsors
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Gangnam Severance Hospital
OTHER
Responsible Party
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Young Song
Associcate Professor
Locations
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Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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3-2023-0338
Identifier Type: -
Identifier Source: org_study_id
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