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

NCT06165562 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Thyroid Surgery

Interventions

PROCEDURE

PSV

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

PROCEDURE

Intermittent Manual Assistance

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

PROCEDURE

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

PROCEDURE

Obey Command

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

PROCEDURE

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

Sponsors & Collaborators

  • Gangnam Severance Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06165562 on ClinicalTrials.gov