CClinicalTrials.gg
CompletedNCT06608602Updated Dec 19, 2025

Tidal Volume Adjustment According to Forced Vital Capacity Versus Predicted Body Weight in Thoracic Surgery Patients

An observational study in Thoracic Surgery, Tidal Volume and Forced Vital Capacity, sponsored by Cukurova University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Cukurova University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
140
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients over 18 years of age and American Society of Anesthesiologists (ASA) physical status I-III who scheduled for elective thoracic surgery under general anesthesia will be included. Exclusion criteria: age > 18 years old, ASA I-III; 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, and missing data.

In the operating room, all patients will be monitored with electrocardiogram, pulse oximeter, non-invasive arterial blood pressure. Anesthesia management, intraoperative and postoperative fluid management, postoperative analgesia regimens were will be standard procedures at the clinic for all patients.

During two-lung ventilation (TLV), mechanical ventilation will be set for a tidal volume (TV) of 7 ml/predicted body weight (PBW) for Group I, FVC/8 ml for Group II. Other settings will be similar between two groups; respiratory rate of 10-14 breaths/min, inspiratory time (Ti) of 33% without inspiratory pause.

Demographic data, functional status, ARISCAT score, hemodynamic values, respiratory measurements (peripheral oxygen saturation: SpO2, Ppeak, Pplato, TV, lung compliances, FiO2, end-tidal carbon dioxide: EtCO2), blood gas analysis (PaO2, PaCO2), and PaO2/ FiO2 rate will be recorded after intubation on TLV (T1), after lateral position on TLV (T2), after 30 min onset OLV (T3), the end of OLV on TLV (T4), and before extubation on TLV (T5).

Duration of anesthesia, duration of OLV, urine output, estimated blood loss, fluid therapy (ml, crystalloid and colloid), the need for blood product (ml), intraoperative complications, and the need for inotrope or vasopressor agent will also recorded during surgery.

The patients will be visited during postoperative five days (day 1: postoperative first day) and respiratory complications (pneumonia, pneumothorax, additional oxygen therapy, respiratory failure, acute respiratory distress syndrome, unplanned invasive or noninvasive mechanical ventilation, prolonged air leak, pleural effusion, atelectasis, cardiopulmonary edema) will be evaluated and recorded daily.

Length of hospital stay and in-hospital mortality will be also recorded. Hospitalization or intensive care unit admission within 30 days after surgery and mortality at 28 days will be assessed by calling the patients and their relatives by phone.

02

Conditions studied

  • Thoracic Surgery
  • Tidal Volume
  • Forced Vital Capacity
  • Predicted Body Weight
03

In context

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients scheduled for elective thoracic surgery under general anesthesia

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
140 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othertidal volume adjustment during surgery

    tidal volume adjustment during surgery according to body weight or FVC

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

  2. lung compliance (mL/cmH2O)

    static and dynamic compliance

    Time frame: 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

  1. postoperative pulmonary complications

    Postoperative pulmonary complications were defined pneumonia, pneumothorax, additional oxygen therapy, respiratory failure, acute respiratory distress syndrome, unplanned invasive or noninvasive mechanical ventilation, prolonged air leak, pleural effusion, atelectasis, and cardiopulmonary edema.

    Time frame: Through postoperative 5 days

  2. Length of hospital stay (day)

    from the day of surgery until the day of discharge

    Time frame: Through postoperative period, an avarage of 5 days

07

Study locations

2 sites
  • Cukurova University Faculty of Medicine Anesthesiology Department
    Adana, Adana 01380, Turkey (Türkiye)
  • Cukurova University Faculty of Medicine Anesthesiology Department
    Adana, 01330, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06608602
Lead sponsor
Cukurova University
Responsible party
mediha turktan (dr, Cukurova University) — Principal investigator
First posted
Sep 23, 2024
Start date
Sep 20, 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Dec 19, 2025

Study contacts

mediha Turktan, MD
principal investigator · Cukurova University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion