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Clinical Trials/NCT06356649
NCT06356649
Completed
N/A

Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes on Respiratory System Complications During Extubation

Eskisehir Osmangazi University1 site in 1 country199 target enrollmentMarch 15, 2023
ConditionsAnesthesia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Eskisehir Osmangazi University
Enrollment
199
Locations
1
Primary Endpoint
Complications developing during recovery-extubation
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications.

Detailed Description

After informed consent was obtained from the patients, monitoring was performed as we practice in routine anesthesia practice. Pressure controlled ventilation (PCV) mode and positive end-expiratory pressure (PEEP) were used as the mechanical ventilation mode after intubation. After the operation was completed, PCV mode on the mechanical ventilator was continued until the patient was extubated. Afterwards, patients were extubated if they complied with verbal commands and/or swallowed and/or coughed in response to vocal stimuli, pupils were in the midline and conjugated, BIS value was \>80, breathing was regular, and TOF response was \>90%. Hemodynamic and respiratory system complications were recorded during the intraoperative, recovery-extubation and postoperative periods. Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study. In the preoperative period, the patient's demographic data and hemodynamic data, and in the intraoperative period, respiratory data (tidal volume, pressure applied during inspiration, peep, etc.) and hemodynamic data were recorded. Complications recorded during recovery-extubation; desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.

Registry
clinicaltrials.gov
Start Date
March 15, 2023
End Date
January 20, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Eskisehir Osmangazi University
Responsible Party
Principal Investigator
Principal Investigator

Dilek Cetinkaya

Associate Professor

Eskisehir Osmangazi University

Eligibility Criteria

Inclusion Criteria

  • Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study

Exclusion Criteria

  • The patient does not want to participate in the study.
  • Known advanced lung disease, advanced-stage heart disease
  • Switching from laparoscopic surgery to open surgery
  • Surgical procedure exceeds 120 minutes
  • intraoperative bleeding \>500 ml

Outcomes

Primary Outcomes

Complications developing during recovery-extubation

Time Frame: 1 hour

desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.

Secondary Outcomes

  • hemodynamic changes(first 24 hours)
  • hemodynamic data(during 24 hours)

Study Sites (1)

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