Flow Controlled Ventilation in Robot-assisted Laparoscopic Surgery

NCT06256900 | Withdrawn

• 1 other identifier: 2023-02285
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mechanical Ventilation Complication; Postoperative Pulmonary Atelectasis

Keywords

Flow-controlled ventilation; Postoperative pulmonary complications; electrical impedance tomography

Outcome Measures

Primary Outcomes (1)

• Differences in the number of patients developing postoperative pulmonary complications

  Development of PPC (composite endpoint including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, requirement for mechanical ventilation) within the first 5 postoperative days (or until discharge). * Constant postoperative monitoring of clinical features indicating PPC * EIT parameters indicating atelectasis (defined by EIT derived parameters Global Inhomogenity Index, Tidal Impedance Variation, end-expiratory lung impedance) measurement after arrival at the PACU. * Requirement of additional oxygen will be evaluated after transfer to the PACU/ICU. Air test indicating additional oxygen requirement, SpO2 \<90% / \<88% in case of risk of hypercapnic respiratory failure. * If unplanned and continued mechanical ventilation is required after surgery this will count as fulfilled primary endpoint.

  to postoperative day 5/discharge

Secondary Outcomes (6)

• Differences in Clara-Cell 16 serum concentrations

  periprocedural

• Differences in area under the curve of postoperative modified Horovitz index

  first hour after surgery

• Differences in end-tidal to capillary/arterial CO2 gradient

  periprocedural

• Differences in minimal required intraoperative FiO2 concentration

  periprocedural

• Differences in parameters derived from the electrical impedance tomography

  periprocedural

Other Outcomes (1)

• Number of patients developing events defined as safety events

  periprocedural

Study Arms (2)

Flow-controlled ventilation

EXPERIMENTAL

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

Other: Flow-controlled ventilation

Pressure-controlled ventilation

ACTIVE COMPARATOR

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).

Other: Pressure-controlled ventilation

Interventions

Flow-controlled ventilation OTHER

FCV mode during robot-assisted laparoscopic surgery

Also known as: FCV

Flow-controlled ventilation

Pressure-controlled ventilation OTHER

PCVmode during robot-assisted laparoscopic surgery

Also known as: PCV

Pressure-controlled ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded to the participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Physician Anesthesiology, MD

Model Details: Randomized, controlled, single-center study

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 13, 2024
• Study Start: October 29, 2024
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: April 24, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE