Impact of low tidal volume ventilation on postoperative delirium in cardiac surgery
The Effect of Continuous Low Tidal Volume Ventilation During Cardiopulmonary Bypass on Postoperative Delirium: A Prospective Randomized Controlled Trial
This study is testing if using low tidal volume ventilation during heart surgery can help reduce the chances of patients experiencing confusion after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nevsehir Public Hospital Government |
| Locations | 1 site (Konya, Karatay) |
| Trial ID | NCT06752421 on ClinicalTrials.gov |
What this trial studies
This study evaluates how low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) affects the incidence of postoperative delirium in patients undergoing cardiac surgeries. It is a prospective, randomized, controlled trial comparing outcomes between patients receiving LTV ventilation and those undergoing apnea. The primary outcome is the incidence of delirium assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and 30-day mortality/morbidity rates. The study aims to improve patient recovery by enhancing cerebral perfusion and oxygenation during surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing planned cardiac surgeries, specifically CABG, with an ASA physical status of II, III, or IV.
Not a fit: Patients undergoing emergency surgeries or those with pre-existing cognitive impairments will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative delirium, leading to improved recovery and outcomes for cardiac surgery patients.
How similar studies have performed: Other studies have shown promising results with low tidal volume ventilation in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Konya, Karatay
- Konya City Hospital — Konya, Karatay, Turkey (Recruiting)
Study contacts
- Study coordinator: Mehmet Akif Yazar, MD
- Email: makifyazar@hotmail.com
- Phone: 90 332 310 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.