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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Konya City Hospital
RECRUITING
Konya
Contact Information
Primary
Mehmet Akif Yazar, MD
makifyazar@hotmail.com
90 332 310 50 00
Backup
Mustafa Aydemir, MD
drmustafaaydemir02@gmail.com
90 332 310 50 00
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 120
Treatments
No_intervention: Group A: Apnea
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.
Experimental: Group B: Low Tidal Volume (LTV)
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.
Related Therapeutic Areas
Sponsors
Leads: Nevsehir Public Hospital

This content was sourced from clinicaltrials.gov