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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: extubation

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.

• Study Type: Observational
• Enrollment (Actual): 199

Contacts and Locations

Study Locations

• Turkey
  • Odunpazarı
    • Eskisehir, Odunpazarı, Turkey, 26040
      • Eskisehir Osmangazi University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic anesthesia with general anesthesia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Goup 1; Patients extubated after general anesthesia	Procedure: extubation; Complications after extubation
Group 2; Patients with complications after extubation	Procedure: extubation; Complications after extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications developing during recovery-extubation	desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamic changes	heart rate	first 24 hours
hemodynamic data	mean arterial pressure	during 24 hours

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Dilek Çetinkaya, Eskişehir Osmangazi University

Publications and helpful links

General Publications

• 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.
• Patel RI, Hannallah RS, Norden J, Casey WF, Verghese ST. Emergence airway complications in children: a comparison of tracheal extubation in awake and deeply anesthetized patients. Anesth Analg. 1991 Sep;73(3):266-70.
• Juang J, Cordoba M, Ciaramella A, Xiao M, Goldfarb J, Bayter JE, Macias AA. Incidence of airway complications associated with deep extubation in adults. BMC Anesthesiol. 2020 Oct 29;20(1):274. doi: 10.1186/s12871-020-01191-8.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: March 31, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: positive end-expiratory pressure; pressure controlled ventilation; tracheal extubation
• Other Study ID Numbers: ESOGU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No