- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467135
Lung Mechanics and Ventilation Efficiency in Robotic Surgery
Phase-Specific Evaluation of Lung Mechanics and Ventilation Efficiency During Robotic Surgery: A Prospective Observational Cohort Study
Robotic surgery requires pneumoperitoneum and specific surgical positioning such as steep Trendelenburg, reverse Trendelenburg, or supine positioning. These intraoperative conditions may lead to cranial displacement of the diaphragm, reduced lung compliance, and increased airway pressures, potentially impairing respiratory mechanics and gas exchange.
Previous studies have primarily evaluated respiratory mechanics during robotic surgery at single time points or within specific surgical procedures. However, dynamic changes occurring during critical phases of robotic surgery have rarely been evaluated prospectively.
This prospective observational cohort study aims to evaluate phase-specific changes in lung mechanics and ventilation efficiency during robotic surgery. Key parameters including mechanical power (MP), ventilation efficiency index (VEI), static compliance, and driving pressure will be analyzed across predefined intraoperative phases.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation.
Robotic procedures from different surgical specialties such as urology, gynecology, and general surgery will be included.
Description
Inclusion Criteria
- Age ≥ 18 years
- Patients undergoing robotic surgery
- General anesthesia with mechanical ventilation
- Written informed consent
Exclusion Criteria
- Severe chronic pulmonary disease
- Refusal to participate
- Missing intraoperative ventilatory data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Robotic Surgery
Adult patients undergoing robotic surgery under general anesthesia with mechanical ventilation.
Intraoperative respiratory mechanics and gas exchange parameters will be prospectively recorded during predefined phases of robotic surgery (T0-T4).
Parameters include ventilatory settings, airway pressures, arterial blood gas values, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index.
The study evaluates phase-specific changes in lung mechanics and ventilation efficiency during robotic surgical procedures.
|
Prospective recording of ventilatory parameters and respiratory mechanics during robotic surgery under general anesthesia.
Measurements will be obtained at predefined surgical phases (after intubation, pneumoperitoneum initiation, steep Trendelenburg positioning, undocking, and before extubation).
Recorded parameters include tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, arterial blood gas measurements, and calculated indices such as mechanical power, driving pressure, static compliance, and ventilation efficiency index.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventilation Efficiency Index (VEI) change across robotic surgery phases
Time Frame: Intraoperative (T0-T4)
|
Evaluation of VEI changes between predefined intraoperative phases.
|
Intraoperative (T0-T4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mechanical Power Change
Time Frame: intraoperative
|
Evaluation of mechanical power changes across surgical phases.
|
intraoperative
|
|
Static Lung Compliance Change
Time Frame: intraoperative
|
Evaluation of static compliance changes during robotic surgery.
|
intraoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TABED1-26-2262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Robotic Surgery
-
Beth Israel Deaconess Medical CenterFisher and Paykel HealthcareNot yet recruitingRobotic SurgeryUnited States
-
Otto-von-Guericke University MagdeburgRecruiting
-
University of NaplesRecruiting
-
McMaster UniversityNot yet recruitingRobotic Surgery | Bariatric Surgery
-
Chinese University of Hong KongRecruiting
-
The Cooper Health SystemRecruiting
-
University of Illinois at ChicagoCompletedPediatric Robotic SurgeryUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedRobotic Surgery | Kidney DonationNetherlands
-
Nitin Sethi, DNBCompleted
-
Lawson Health Research InstituteCompletedRobotic Surgery Simulation TrainingCanada
Clinical Trials on Intraoperative Mechanical Ventilation Monitoring
-
Guy's and St Thomas' NHS Foundation TrustCompletedSleep Disordered Breathing | COPD | Hypercapnic Respiratory Failure | Obesity Hypoventilation Syndrome (OHS)United Kingdom
-
NMC Specialty HospitalAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Hospital... and other collaboratorsCompletedPostoperative Complications | Surgery | Intraoperative Complications | Mechanical Ventilation Complication | Pulmonary ComplicationSpain, Brazil, Germany, Italy
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...CompletedLung Injury | Pulmonary ComplicationTurkey
-
University Hospital OstravaRecruitingARDS | Lung Injury, Ventilator InducedCzechia
-
University of ThessalyCompleted
-
Azienda Ospedaliera SS. Antonio e Biagio e Cesare...Medical University of Vienna; Monash University; University Of Perugia; The Netherlands... and other collaboratorsRecruitingPostoperative Complications | Surgery | Ventilator LungItaly
-
Peking Union Medical College HospitalThe First Affiliated Hospital with Nanjing Medical University; National Natural... and other collaboratorsUnknownAcute Respiratory Failure | Immunocompromised Patients
-
Ruijin HospitalUnknownAcute Pancreatitis | Complication of Ventilation TherapyChina
-
Riphah International UniversityCompletedBurns (Physical Finding)Pakistan
-
Limin ZhuUnknownRight Ventricular Hypertrophy | Congenital Heart Disease | Postoperative Care | Mechanical Ventilation | Heart-lung InteractionChina