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Recruiting NCT06850844

NCT06850844 Recruitment Maneuvers and PEEP-guided Electrical Impedance Tomography for Abdominal Laparoscopic Surgery Patients

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Clinical Trial Summary
NCT ID NCT06850844
Status Recruiting
Phase
Sponsor Nguyen Dang Thu
Condition Laparoscopic Surgery
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2024-08-01
Primary Completion 2025-12-15

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
electrical impedance tomographyConventional Ventilation

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 70 participants in total. It began in 2024-08-01 with a primary completion date of 2025-12-15.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Abdominal laparoscopy is widely utilized due to its benefits, including minimal invasiveness, improved cosmetic outcomes, and shorter hospital stays. However, the use of intraoperative pneumoperitoneum and general anesthesia with mechanical ventilation may lead to postoperative pulmonary complications, such as atelectasis. This condition can result in diminished respiratory mechanics and impaired gas exchange. In recent years, intraoperative lung-protective mechanical ventilation techniques, including recruitment maneuvers (RMs) and positive end-expiratory pressure (PEEP) strategies, have gained popularity. These approaches aim to prevent the repeated collapse and reopening of alveoli, thereby reducing the risk of atelectasis. Nonetheless, determining the optimal PEEP level for individual patients remains a complicated and unresolved issue. Electrical impedance tomography (EIT) is a bedside imaging technique that assesses regional ventilation distribution, providing a method for personalizing PEEP settings in mechanically ventilated patients. By addressing the competing risks of alveolar overdistension and collapse, EIT enhances the precision of PEEP titration. This study aims to compare the effects of recruitment maneuvers and EIT-guided PEEP selection against conventional ventilation on regional ventilation, gas exchange, and pulmonary mechanics in patients undergoing abdominal laparoscopic surgery.

Eligibility Criteria

Inclusion Criteria: * Age \> 18 years * Scheduled for abdominal laparoscopy surgery * At increased (i.e., intermediate or high) risk of postoperative pulmonary complications according to the "Assess Respiratory Risk in Surgical Patients in Catalonia" (ARISCAT) score (≥ 26 points) * Signed written informed consent Exclusion Criteria: * Major previous lung surgery (e.g., lung resection) * Severe chronic obstructive pulmonary disease and/or severe emphysema * Increased intracranial pressure * Contraindications for EIT (pacemakers, automatic external defibrillators, cases of chest trauma or recent chest surgery limiting EIT belt application) * Presence of pneumothorax that is either undrained or newly occurred. * Unstable hemodynamics with a mean arterial pressure \< 60 mmHg and unresponsive to resuscitation measures, and/or heart rate \< 60 bpm. * Pregnancy. * Severe neuromuscular disease.

Contact & Investigator

Central Contact

Thanh Huyen Thi Pham, M.D

✉ drthanhhuyen368@gmail.com

📞 +84989733699

Frequently Asked Questions

Who can join the NCT06850844 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Laparoscopic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06850844 currently recruiting?

Yes, NCT06850844 is actively recruiting participants. Contact the research team at drthanhhuyen368@gmail.com for enrollment information.

Where is the NCT06850844 trial being conducted?

This trial is being conducted at Hanoi, Vietnam.

Who is sponsoring the NCT06850844 clinical trial?

NCT06850844 is sponsored by Nguyen Dang Thu. The trial plans to enroll 70 participants.

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