NCT06356649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

10 months

First QC Date

March 31, 2024

Last Update Submit

April 9, 2024

Conditions

Keywords

pressure controlled ventilationpositive end-expiratory pressuretracheal extubation

Outcome Measures

Primary Outcomes (1)

  • Complications developing during recovery-extubation

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

    1 hour

Secondary Outcomes (2)

  • hemodynamic changes

    first 24 hours

  • hemodynamic data

    during 24 hours

Study Arms (2)

Goup 1

Patients extubated after general anesthesia

Procedure: extubation

Group 2

Patients with complications after extubation

Procedure: extubation

Interventions

extubationPROCEDURE

Complications after extubation

Goup 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing laparoscopic anesthesia with general anesthesia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskisehir Osmangazi University Medical Faculty

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 1867418BACKGROUND
  • 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.

    PMID: 34610099BACKGROUND
  • 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.

  • Ata AR, Cetinkaya D, Yaman F. Investigating the effects of pressure support ventilation and positive end-expiratory pressure during extubation on respiratory system complications. Perioper Med (Lond). 2024 Dec 18;13(1):118. doi: 10.1186/s13741-024-00477-6.

MeSH Terms

Interventions

Airway Extubation

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsInvestigative Techniques

Study Officials

  • Dilek Çetinkaya

    Eskisehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 10, 2024

Study Start

March 15, 2023

Primary Completion

January 15, 2024

Study Completion

January 20, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations