Flow Controlled Ventilation in Robot-assisted Laparoscopic Surgery

NCT ID: NCT06256900

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2024-10-29

Brief Summary

The optimization of ventilation is especially important during general anaesthesia, when active, physiologic respiration suspends and is replaced by non-physiologic mechanical positive pressure ventilation. Aiming at preserving compliance of lung tissue to guarantee an effective gas exchange is to avoid an excessive pressure application, especially in extreme positioning of the patient (Trendelenburg positioning) and/or pneumoperitoneum resulting in additional non-physiologic intrathoracic pressure. Perioperative lung protection strategies have steadily improved in recent years to reduce complications from mechanical ventilation, but postoperative pulmonary complications remain a risk factor for increased morbidity and mortality.

Detailed Description

Mechanical ventilation is crucial during general anesthesia, with ongoing efforts to refine strategies for optimal respiratory support. Important articles on perioperative ventilation explored key aspects, including PEEP application, tidal volume effects, PPC after major surgeries, and perioperative oxygen titration to mitigate oxidative stress. PEEP plays a pivotal role in enhancing oxygenation and preventing atelectasis during mechanical ventilation. Landmark studies by the ARDS Network highlight the importance of customizing PEEP application. This tailored approach not only improves respiratory mechanics but also reduces the risk of barotrauma, underscoring the crucial impact of personalized PEEP strategies. Concurrently, adopting a lung-protective strategy with low tidal volumes, has proven effective in mitigating ventilator-induced lung injury. These strategies aim to strike a balance between optimal oxygenation and minimizing potential complications associated with mechanical ventilation. Despite advancements in perioperative care, PPC remain a concern, particularly following major surgical procedures. Recent investigations emphasize the multifactorial nature of these complications. Early identification of risk factors and meticulous monitoring are crucial to reducing the incidence of complications such as atelectasis, pneumonia, and respiratory insufficiency. Understanding the interplay between mechanical ventilation strategies and postoperative outcomes is essential for improving patient recovery. The pursuit of optimal oxygenation must be balanced against the potential for oxygen toxicity and oxidative stress. Available studies shed light on the delicate equilibrium required in maintaining adequate oxygen delivery while avoiding the detrimental effects of hyperoxia. Clinicians must consider individual patient factors and tailor oxygen therapy to prevent oxidative stress, which can contribute to tissue damage and compromise overall patient well-being. FCV is a new ventilation strategy designed to minimize the mechanical effects of perioperative ventilation on lung tissue. Compared to traditionally employed ventilation strategies, gas flow is controlled during both inspiration and expiration in FCV. In particular, the almost linear pressure drop during the expiratory phase of FCV has been shown in various ex vivo/experimental and clinical studies to improve gas exchange and the proportion of ventilated lung tissue.

Ongoing advancements in mechanical ventilation shape anesthesia practices with a focus on evidence-based approaches for patient safety. Building on prior findings, this study explores the benefits of the novel ventilation approach, FCV, aiming to reduce dissipative energy and alveolar stress. The investigators hypothesize positive impacts on perioperative ventilation, vital parameters, and a decreased incidence of PPC, contributing to overall postoperative morbidity and mortality reduction.

Conditions

Mechanical Ventilation Complication; Postoperative Pulmonary Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Flow-controlled ventilation

Experimental intervention FCV (EVONE, Ventinova Medical): PEEP and Peak inspiratory pressure titration guided by dynamic compliance.

Group Type: EXPERIMENTAL

Flow-controlled ventilation

Intervention Type: OTHER

FCV mode during robot-assisted laparoscopic surgery

Pressure-controlled ventilation

Control intervention PCV (Dräger Medical, Atlan A350): lung-protective ventilation to current best practice. Settings determined by the attending anesthesiologist (based on the internal SOP: intraoperative ventilation in robot-assisted laparoscopic surgery).

Group Type: ACTIVE_COMPARATOR

Pressure-controlled ventilation

Intervention Type: OTHER

PCVmode during robot-assisted laparoscopic surgery

Interventions

Flow-controlled ventilation

FCV mode during robot-assisted laparoscopic surgery

Intervention Type: OTHER

Pressure-controlled ventilation

PCVmode during robot-assisted laparoscopic surgery

Intervention Type: OTHER

Other Intervention Names

FCV; PCV

Eligibility Criteria

Inclusion Criteria

• Patient undergoing elective robot-assisted laparoscopic surgery (either abdominal, urologic or gynecologic surgery) with a duration of expected ventilation of ≥ 90 minutes
• Male or female aged ≥ 18 years
• ASA Physical Status Classification System score I - III
• Must be willing and able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention

Exclusion Criteria

• Patient with weight < 40 kg ideal body weight
• ASA Physical Status Classification System score IV - VI
• Previous enrolment into the current study
• Enrolment of study investigator, his/her family members, employees and other dependent persons
• If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Dr. Timur Yurttas

Principal Investigator, Senior Physician Anesthesiology, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2023-02285

Identifier Type: -

Identifier Source: org_study_id