NCT06608602

Brief Summary

The goal of this observational study is to learn about the intraoperative and postoperative pulmonary effects of tidal volume adjustment according to force vital capacity in thoracic surgery patients. The main question it aims to answer is: Is there any positive effect of tidal volume adjustment according to force vital capacity on intraoperative and postoperative lung function in thoracic surgery patients? Participants already taking tidal volume adjustment according to force vital capacity or predicted body weight during toracic surgery. As part of the medical care of thoracic surgery patients, intraoperative hemodynamic variables, lung dynamics and blood gas values and postoperative pulmonary complications will be monitored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

December 19, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

September 11, 2024

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • intraoperative oxygenation (PaO2/FiO2 ratio)

    The ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspiratory oxygen concentration (FiO2) is an indicator of pulmonary shunt fraction.

    5 time during surgery (T1:after intubation on TLV, T2: after lateral position on TLV, T3: after 30 min onset OLV, T4: the end of OLV on TLV, T5: before extubation on TLV

  • lung compliance (mL/cmH2O)

    static and dynamic compliance

    5 time during surgery (T1:after intubation on TLV, T2: after lateral position on TLV, T3: after 30 min onset OLV, T4: the end of OLV on TLV, T5: before extubation on TLV

Secondary Outcomes (2)

  • postoperative pulmonary complications

    Through postoperative 5 days

  • Length of hospital stay (day)

    Through postoperative period, an avarage of 5 days

Study Arms (1)

Group I and Group II

Group I= tidal volume 7 ml/predicted body weight Group II= tidal volume FVC/8 ml

Other: tidal volume adjustment during surgery

Interventions

tidal volume adjustment during surgery according to body weight or FVC

Group I and Group II

Eligibility Criteria

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

patients scheduled for elective thoracic surgery under general anesthesia

You may qualify if:

  • Patients over 18 years of age
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective thoracic surgery under general anesthesia

You may not qualify if:

  • Age over 18 years old,
  • ASA \> III,
  • Pregnancy,
  • Presence of large bullae and/or pneumothorax,
  • Previous lung resection surgery,
  • Intensive care unit (ICU) admission in the preoperative period,
  • Predictive postoperative ICU admission,
  • Pneumonectomy surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cukurova University Faculty of Medicine Anesthesiology Department

Adana, Adana, 01380, Turkey (Türkiye)

Location

Cukurova University Faculty of Medicine Anesthesiology Department

Adana, 01330, Turkey (Türkiye)

Location

Study Officials

  • mediha Turktan, MD

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 23, 2024

Study Start

September 20, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

December 19, 2025

Record last verified: 2025-01

Locations