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

NCT06850844 | Recruiting

• 2 other identifiers: HuyenGMHS 5509/BM-HDDDNo.5509/BM-HDDD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Surgery; Positive End-Expiratory Pressure; Electrical Impedance Tomography

Keywords

Laparoscopic Surgery; Positive End-Expiratory Pressure; Recruitment Maneuver; electrical impedance tomography; blood oxygenation; regional ventilation; pulmonary mechanics

Outcome Measures

Primary Outcomes (3)

• Regional Lung Ventilation

  Evaluation of Ventilation Distribution With Electrical Impedance Tomography

  During surgery

• Oxygenation

  PaO2/FiO2 will be evaluated via arterial blood gas analysis

  During surgery, and at day 1 post-operative

• Pulmonary Mechanic

  Static Compliance

  During surgery

Secondary Outcomes (7)

• Pneumothorax or barotrauma

  During surgery

• Hemodynamic instability

  During surgery

• Respiratory failure

  Up to 5 days after surgery

• Bronchospasm

  Up to 5 days after surgery

• Suspected pulmonary infection

  Up to 5 days after surgery

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Patients were applied recruitment maneuvers and EIT-guided PEEP during ventilation during general anesthesia.

Device: electrical impedance tomography

Control Group

PLACEBO COMPARATOR

Patients will receive a constant PEEP of 5 cm H2O without RMs throughout the entire intraoperative ventilation period

Device: Conventional Ventilation

Interventions

electrical impedance tomography DEVICE

The individualized high PEEP with RMs group commences with a PEEP of 5 cm H2O and undergo an RM followed by a decremental PEEP trial. Pressure-controlled ventilation mode is set with a respiratory rate of 16 breaths per minute and ΔP=15 (ΔP is calculated by subtracting PEEP from the plateau pressure (Pplat). In intervals of 5 breaths, PEEP is incrementally increased by 5 cm H2O, starting at 5 cm H2O and reaching up to 20 cm H2O. The decremental PEEP trial is immediately performed following the first RM, beginning at a PEEP of 20 cm H2O with a respiratory rate of 15 breaths per minute. Every 30 seconds, PEEP is decreased by increments of 2 cm H2O until it reaches a minimum of 6 cm H2O. This decremental PEEP trial is succeeded by a second RM, after which the individualized PEEP level will be established as determined by the decremental PEEP trial and sustained until the completion of ventilation.

Intervention Group

Conventional Ventilation DEVICE

Ventilation is set in volume-controlled mode with a tidal volume of 7 ml/kg predicted body weight (PBW), the respiratory rate is adjusted to target normocapnia (end-tidal carbon dioxide partial pressure between 35 and 45 mmH), an inspiratory to expiratory ratio of 1:2, and a PEEP of 5 cmH2O.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nguyen Dang Thu: lead
• Bach Mai Hospital: collaborator
• Hanoi Medical University: collaborator

Study Sites (1)

Anesthesia Center, Bach Mai Hospital

Hanoi, 10000, Vietnam

RECRUITING

Related Publications (4)

• Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.

  PMID: 23196259 RESULT

• Karsten J, Luepschen H, Grossherr M, Bruch HP, Leonhardt S, Gehring H, Meier T. Effect of PEEP on regional ventilation during laparoscopic surgery monitored by electrical impedance tomography. Acta Anaesthesiol Scand. 2011 Aug;55(7):878-86. doi: 10.1111/j.1399-6576.2011.02467.x. Epub 2011 Jun 9.

  PMID: 21658014 RESULT

• Nestler C, Simon P, Petroff D, Hammermuller S, Kamrath D, Wolf S, Dietrich A, Camilo LM, Beda A, Carvalho AR, Giannella-Neto A, Reske AW, Wrigge H. Individualized positive end-expiratory pressure in obese patients during general anaesthesia: a randomized controlled clinical trial using electrical impedance tomography. Br J Anaesth. 2017 Dec 1;119(6):1194-1205. doi: 10.1093/bja/aex192.

  PMID: 29045567 RESULT

• Erlandsson K, Odenstedt H, Lundin S, Stenqvist O. Positive end-expiratory pressure optimization using electric impedance tomography in morbidly obese patients during laparoscopic gastric bypass surgery. Acta Anaesthesiol Scand. 2006 Aug;50(7):833-9. doi: 10.1111/j.1399-6576.2006.01079.x.

  PMID: 16879466 RESULT

Central Study Contacts

Thanh Huyen Thi Pham, M.D

CONTACT

+84989733699; drthanhhuyen368@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D; M.D.

Model Details: Prospective, single center, randomized controlled trial

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: August 1, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)