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

ConditionsLaparoscopic SurgeryPositive End-Expiratory PressureElectrical Impedance Tomography
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNguyen Dang Thu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Regional Lung Ventilation

Evaluation of Ventilation Distribution With Electrical Impedance Tomography

Time frame
During surgery
2

Oxygenation

PaO2/FiO2 will be evaluated via arterial blood gas analysis

Time frame
During surgery, and at day 1 post-operative
3

Pulmonary Mechanic

Static Compliance

Time frame
During surgery

Secondary outcomes

1

Pneumothorax or barotrauma

New-onset of pneumothorax and barotrauma

Time frame
During surgery
2

Hemodynamic instability

New-onset of Bradycardia and/or hypotension

Time frame
During surgery
3

Respiratory failure

pO2 less than 60 mm Hg (or room air oxygen saturation less than or equal to 90%), pCO2 greater than 50 mm Hg with pH less than 7.35, and signs/symptoms of respiratory distress

Time frame
Up to 5 days after surgery
4

Bronchospasm

Symptoms and signs of acute bronchospasm include wheezing, prolonged expiration, reduced breath sounds

Time frame
Up to 5 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nguyen Dang Thu

Lead sponsor

Vietnam Military Medical University

Sponsor institution

Bach Mai Hospital

Collaborator

Hanoi Medical University

Collaborator

Source ClinicalTrials.gov
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