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Effect of Low Tidal Volume Ventilation on Postoperative Delirium

NCT06752421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Nevsehir Public Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-08
Completion
2026-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06752421 on ClinicalTrials.gov