NCT06752421

Effect of Low Tidal Volume Ventilation on Postoperative Delirium

The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Postoperative Delirium: A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Nevsehir Public Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. It is hypothesized that the risk of delirium, which negatively impacts recovery following cardiac surgeries, can be reduced by improving cerebral perfusion and oxygenation through LTV. The study is designed as a prospective, randomized, controlled trial comparing delirium incidence, ICU stay duration, and 30-day mortality/morbidity rates between LTV and apnea groups. Primary outcomes will be assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and mortality/morbidity rates.

Detailed description

Introduction and Objectives: This protocol aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. Postoperative delirium, commonly seen after cardiac surgeries, negatively impacts patient recovery. It is hypothesized that LTV reduces the risk of delirium by improving cerebral perfusion and oxygenation. The study objectives include comparing the incidence of delirium, ICU stay duration, and 30-day mortality/morbidity rates between groups. Study Design and Methods: This prospective, randomized, controlled trial will involve two groups: patients receiving LTV ventilation and those undergoing apnea during CPB. Inclusion criteria target CABG patients over 18 years of age, while exclusion criteria include emergent surgeries and cognitive impairments. Randomization will ensure balanced group allocation through computer-based methods. Mechanical ventilation parameters will follow standard protocols for both groups. Measurements and Hypotheses: The primary outcome is delirium, assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and 30-day composite mortality/morbidity rates. LTV ventilation is expected to reduce delirium incidence, shorten ICU stay, and lower mortality/morbidity rates. Statistical analyses will include multivariable models to account for potential confounding factors. Substudies and Limitations: The protocol includes two substudies to evaluate microcirculation and renal perfusion. Limitations may arise from the overlap of sedation effects with delirium symptoms, variations in surgical techniques, and potential data loss during patient follow-ups. Interim analyses are planned to assess the study's safety and effectiveness. The study will be conducted without external funding, adhering to routine clinical practices.

Conditions

• Postoperative Delirium (POD)
• Cardiopulmonary Bypass
• Low Tidal Volume Ventilation
• Cognitive Dysfunction, Postoperative

Interventions

Type	Name	Description
PROCEDURE	Group B: Low tidal volume	In the LTV group, mechanical ventilation will be maintained with low tidal volume parameters after the aortic cross-clamp procedure. This intervention includes a tidal volume of 3-4 mL/kg, respiratory rate of 12-14 breaths/min, PEEP of 5-8 cmH₂O, and FiO₂ of 50%. Minute ventilation (MV) will not exceed 12 L, and the parameters are adjusted according to ideal body weight. This group is designed to evaluate the protective effects of low tidal volume ventilation during surgery.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-08
• Completion: 2026-02-28
• First posted: 2024-12-30
• Last updated: 2026-03-31

Locations

1 site across 1 country: Turkey (Türkiye)