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Comparison of Standard Versus Dynamic Compliance-Guided Individualized PEEP in Obese Patients Undergoing Spinal Surgery

K

Konya City Hospital

Status

Completed

Conditions

Postoperative Pulmonary Complications
Obesity
Mechanical Ventilation

Treatments

Device: Standard PEEP

Study type

Interventional

Funder types

Other

Identifiers

NCT07388719
NEU-2024-5206

Details and patient eligibility

About

This study aims to compare standard positive end-expiratory pressure (PEEP) with dynamic compliance-guided individualized PEEP in obese patients undergoing elective spinal surgery under general anesthesia. Obesity and prone positioning during spinal surgery are associated with reduced lung compliance, atelectasis, and an increased risk of postoperative pulmonary complications.

Participants will be allocated to receive either a fixed standard PEEP or an individualized PEEP level determined according to intraoperative dynamic lung compliance. Intraoperative oxygenation, respiratory mechanics, arterial blood gas parameters, and hemodynamic variables will be assessed at predefined time points. Postoperative pulmonary complications within the first 24 hours after surgery will also be evaluated.

The study seeks to determine whether individualized PEEP titration based on dynamic compliance offers physiological or clinical advantages compared with a standard PEEP strategy in this patient population.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients aged 18-65 years
  • Body mass index (BMI) ≥30 kg/m²
  • Scheduled for elective spinal surgery under general anesthesia
  • Requirement for intraoperative mechanical ventilation
  • American Society of Anesthesiologists (ASA) physical status II-III
  • Provision of written informed consent

Exclusion criteria

  • Pre-existing severe pulmonary disease (e.g., COPD GOLD stage III-IV, restrictive lung disease)
  • Severe cardiac disease (e.g., heart failure with reduced ejection fraction, significant valvular disease)
  • History of thoracic surgery affecting lung mechanics
  • Pregnancy
  • Emergency surgery
  • Intraoperative need for deviation from the planned ventilation protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Standard PEEP
Active Comparator group
Description:
Patients assigned to this arm receive a fixed positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the intraoperative period during mechanical ventilation.
Treatment:
Device: Standard PEEP
Dynamic Compliance-Guided Individualized PEEP
Experimental group
Description:
Patients assigned to this arm receive individualized positive end-expiratory pressure (PEEP) titrated according to intraoperative dynamic lung compliance, with the aim of optimizing respiratory mechanics while avoiding overdistension.
Treatment:
Device: Standard PEEP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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