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RecruitingNCT07875530Updated Oct 15, 2026

VC-AF vs FCV in Obese Patients Undergoing Laparoscopic Surgery

An observational study in Anesthesia, Mechanical Ventilation and Obesity, sponsored by Kocaeli University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Kocaeli University · Observational

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
78
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Obesity adversely affects respiratory physiology by reducing lung volumes and compliance and increasing airway resistance and alveolar collapse. These effects are further aggravated by pneumoperitoneum during laparoscopic surgery, increasing the risk of impaired oxygenation and ventilator-induced lung injury (VILI).

Mechanical power (MP) reflects the total energy transferred to the respiratory system during mechanical ventilation and is influenced by tidal volume, respiratory rate, airway pressures, flow, and PEEP. Increased airway and driving pressures may contribute to higher mechanical power and lung injury, particularly in obese patients undergoing laparoscopic surgery.

This study aims to compare flow-controlled ventilation (FCV) and volume-controlled ventilation with autoflow (VC-AF) in obese patients undergoing laparoscopic surgery in terms of airway pressures, driving pressure, and mechanical power. The investigators hypothesize that FCV may reduce airway pressures, driving pressure, and mechanical power compared with VC-AF, potentially decreasing the risk of VILI. The effect of FCV on oxygenation will also be evaluated as a secondary outcome.

Read the detailed description

Obesity is an important risk factor that adversely affects respiratory physiology during the perioperative period, leading to reduced lung volumes, increased airway resistance, and early alveolar collapse. During laparoscopic surgery, pneumoperitoneum and increased intra-abdominal pressure further reduce lung volumes, decrease lung compliance, and promote alveolar collapse. Therefore, obese patients represent a high-risk population for both impaired oxygenation and ventilator-induced lung injury (VILI) during the perioperative period.

Ventilator-induced lung injury is associated not only with high airway pressures and tidal volumes but also with the total amount of energy transferred to the lungs during mechanical ventilation. In this context, mechanical power is considered a comprehensive parameter reflecting the combined effects of tidal volume, respiratory rate, airway pressures, flow, and PEEP. Mechanical power is calculated using ventilation parameters according to the following formula:

MP = 0.098 × RR × VT (L) × (PIP - 0.5 × Driving Pressure) Airway pressures, particularly driving pressure, are key components of mechanical power, and increases in these parameters are closely associated with lung injury.

In obese patients undergoing ventilation during pneumoperitoneum, increased intrathoracic pressure and reduced lung compliance may result in higher airway pressures. This may increase mechanical power and consequently increase the risk of lung injury.

The present study aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation with autoflow (VC-AF) on airway pressures, driving pressure, and mechanical power in obese patients undergoing laparoscopic surgery. The investigators hypothesize that, compared with VC-AF, FCV may reduce mechanical power by generating lower airway pressures and driving pressures, thereby potentially reducing the risk of ventilator-induced lung injury. In addition, whether FCV improves oxygenation by providing more homogeneous alveolar ventilation will be evaluated as a secondary outcome.

02

Conditions studied

  • Anesthesia
  • Mechanical Ventilation
  • Obesity

Keywords

  • Flow-Controlled Ventilation (FCV)
  • Volume-Controlled Ventilation (VCV)
  • Laparoscopic Surgery Obese Patient
  • Obese Patients
  • Intraoperative Mechanical Ventilation
  • Pneumoperitoneum
03

In context

Obesity

6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 78 is below the median of 132 across 1,338 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Kocaeli University is the lead sponsor of 214 studies on the registry; 39 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with a BMI ≥30 kg/m² undergoing laparoscopic surgery under general anesthesia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥18 years Body mass index (BMI) ≥30 kg/m² American Society of Anesthesiologists (ASA) Physical Status I-III Scheduled to undergo elective laparoscopic surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

Pregnancy Emergency surgery Presence of a cardiac pacemaker Chronic obstructive pulmonary disease (COPD)

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
78 participants (estimated)
Patient registry
No

Groups and cohorts

  • Flow-Controlled Ventilation (FCV)
  • Volume-Controlled Ventilation (VCV)
06

What researchers measure

Primary outcomes

  1. Mechanical Power (J/min)

    Data will be recorded during surgery

    Time frame: peroperative

  2. Driving Pressure (cmH₂O)

    Data will be recorded during surgery

    Time frame: peroperative

  3. Plateau Airway Pressure (cmH₂O)

    Data will be recorded during surgery

    Time frame: peroperative

  4. Peak Airway Pressure (cmH₂O)

    Data will be recorded during surgery

    Time frame: peroperative

Secondary outcomes

  1. Oxygenation Assessed by PaO₂/FiO₂ Ratio

    Data will be recorded during surgery

    Time frame: peroperative

07

Study locations

1 of 1 sites recruiting
  • Kocaeli University Faculty of Medicine
    Kocaeli, Izmit 41100, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875530
Lead sponsor
Kocaeli University
Responsible party
Elif Balcı Koç (Reseacrh Assistant Doctor, Kocaeli University) — Principal investigator
First posted
Oct 15, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
Jun 21, 2027 (estimated)
Completion
Sep 21, 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Elif Balcı Koç, MD
Contact
elfblc67@gmail.com
+90 543 487 10 38
Sevim Cesur Okan, Associate Professor
Contact
svmcsr@gmail.com
+90 541 911 41 00

Oversight

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

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