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Completed

NCT Number: NCT06356649

Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eskisehir Osmangazi University Medical Faculty

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extubation

Procedure

Complications after extubation

Primary outcomes

  1. 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

  1. hemodynamic changes

    Time frame: first 24 hours

    heart rate

  2. hemodynamic data

    Time frame: during 24 hours

    mean arterial pressure

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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