NCT05776589

Brief Summary

In this study, it was aimed to compare the effects of pressure-controlled volume-guaranteed ventilation (PCV-VG) and volume-controlled ventilation (VCV) on lung dynamics and hemodynamics in patients undergoing vertebral surgery in the prone position.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

February 25, 2023

Last Update Submit

March 8, 2023

Conditions

Mechanical Ventilation

Keywords

lung dynamics under general anesthesiaprone positionpressure controlled modevolume controlled modevertabral surgery

Outcome Measures

Primary Outcomes (1)

  • Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on lung compliance

    Comparison of the effects of pressure controlled volume guaranteed ventilation (PCV-VG) and volume controlled ventilation (VCV) on lung compliance (ml/cmH20) in patients undergoing vertebral surgery in a prone position

    3 months

Secondary Outcomes (2)

  • Comparison of the effects of pressure controlled volume guaranteed ventilation and volume controlled ventilation on heart rate

    3 months

  • Comparison of the effects of pressure-controlled volume guaranteed ventilation and volume-controlled ventilation on mean arterial pressure

    3 months

Study Arms (2)

Group PCV-VG

In this group, pressure-controlled volume guaranteed ventilation (PCV- VG) was applied in patients undergoing vertebral surgery in the prone position.

Device: The mechanical ventilation mode

Group VCV

In this group, volume-controlled ventilation (VCV) was applied in patients undergoing vertebral surgery in the prone position.

Device: The mechanical ventilation mode

Interventions

The mechanical ventilation modeDEVICE

Changing the mechanical ventilation mode

Group PCV-VGGroup VCV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing vertebral surgery in the prone position.

You may qualify if:

  • Patients who will undergo thoracolumbar vertebral surgery in the prone position
  • Patients older than 18 years
  • Patients younger than 70 years of age
  • ASA 1-2 patients

You may not qualify if:

  • Patients with a BMI \>30 kg/m2
  • Patients with a history of chronic pulmonary disease
  • Patients with a history of previous thoracic surgery
  • Patients with ASA \>3
  • Patients who will undergo emergency surgery
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KCU Izmir Atatürk Training and Research Hospital

Izmir, 35150, Turkey (Türkiye)

RECRUITING

Study Officials

  • Derya A Yurtlu, M.D.

    Izmir Atatürk Training and Reseach Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derya A Yurtlu, M.D.

CONTACT

+0905058764132darslanyurtlu@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 25, 2023

First Posted

March 20, 2023

Study Start

February 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

March 20, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)