Effect of Low Tidal Volume Ventilation on Postoperative Delirium

NCT06752421 | Completed

• 1 other identifier: TABED-24-851
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Postoperative Delirium; Cardiopulmonary Bypass; low tidal volume ventilation; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium incidence

  The main objective of the study is to compare the rates of postoperative delirium between patients who received low tidal volume (LTV) ventilation and those who were apnea-induced during CABG surgeries. This will be measured by the incidence of delirium, and it will be statistically analyzed to determine whether there is a significant difference between the two groups.

  From the point where the RASS score evaluating wakefulness is -3, for a duration of 48 hours

Secondary Outcomes (3)

• Length of stay in the intensive care unit (ICU)

  The duration will be recorded in hours, starting from the time of ICU admission to the time of discharge.

• 30-day mortality rate

  In the first 30 days after surgery

• 30-day morbidity rate

  In the first 30 days after surgery

Study Arms (2)

Group A: Apnea

NO INTERVENTION

The apnea group serves as the control group. In routine Coronary Artery Bypass Grafting (CABG) surgery, after the cross clamp procedure, the mechanical ventilator is turned off, and the process is maintained by cardiopulmonary bypass (CPB). In this group, no mechanical ventilation will be provided after the cross clamp procedure, and apnea will be applied as part of routine care. The process will be entirely maintained by CPB.

Group B: Low Tidal Volume (LTV)

EXPERIMENTAL

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.

Procedure: Group B: Low tidal volume

Interventions

Group B: Low tidal volume PROCEDURE

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.

Group B: Low Tidal Volume (LTV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All male or female patients over the age of 18
• Patients undergoing planned cardiac surgeries including CABG
• Patients with an American Society of Anesthesiologists (ASA) physical status of II, III, or IV

You may not qualify if:

• Emergency surgeries will be excluded due to the high likelihood of non-compliance with the protocol and the potential lack of essential patient information.
• Surgeries requiring single-lung ventilation will be excluded as they may cause confusion in determining any effects of the intervention due to the inability to apply the study intervention and the differential treatment of the lungs.
• Patients who meet delirium criteria according to 3D-CAM measurements during the initial visit will be excluded.
• Patients with a life expectancy of less than 6 months or a history of psychiatric or neurological diseases (including depression, severe central nervous system depression, schizophrenia, epilepsy, Parkinson's disease, and Alzheimer's disease) will be excluded.
• Severe impairments such as blindness, severe deafness, or dementia that may hinder cognitive testing will be excluded.
• Patients using psychotropic or opioid medications, those with a history of delirium, or those with a history of alcohol abuse or withdrawal within the past 6 months will be excluded.

Sponsors & Collaborators

• Nevsehir Public Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: During cardiopulmonary bypass (CPB), apnea is routinely performed. In the control group, apnea ventilation will be continued, while in the intervention group, low tidal volume (LTV) ventilation will be applied.

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 30, 2024
• Study Start: January 1, 2025
• Primary Completion: December 8, 2025
• Study Completion: February 28, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)