Tidal Volume Adjustment According to Forced Vital Capacity Versus Predicted Body Weight in Thoracic Surgery Patients
The Pulmonary Effects of Tidal Volume Adjustment According to Forced Vital Capacity Versus Predicted Body Weight in Thoracic Surgery Patients
1 other identifier
observational
140
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2024
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2024
CompletedStudy Start
First participant enrolled
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedDecember 19, 2025
January 1, 2025
4 months
September 11, 2024
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
Interventions
tidal volume adjustment during surgery according to body weight or FVC
Eligibility Criteria
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)
Cukurova University Faculty of Medicine Anesthesiology Department
Adana, 01330, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
mediha Turktan, MD
Cukurova University
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