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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Surgery; Tidal Volume; Forced Vital Capacity; Predicted Body Weight
• Intervention / Treatment: Other: tidal volume adjustment during surgery

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.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients scheduled for elective thoracic surgery under general anesthesia

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; tidal volume adjustment during surgery according to body weight or FVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through postoperative 5 days
Length of hospital stay (day)	from the day of surgery until the day of discharge	Through postoperative period, an avarage of 5 days

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: mediha Turktan, MD, Çukurova University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: TV01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No