NCT07467135

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
0mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

12 days

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ventilation Efficiency Index (VEI) change across robotic surgery phases

    Evaluation of VEI changes between predefined intraoperative phases.

    Intraoperative (T0-T4)

Secondary Outcomes (2)

  • Mechanical Power Change

    intraoperative

  • Static Lung Compliance Change

    intraoperative

Study Arms (1)

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.

Other: Intraoperative Mechanical Ventilation Monitoring

Interventions

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.

Robotic Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age ≥ 18 years
  • Patients undergoing robotic surgery
  • General anesthesia with mechanical ventilation
  • Written informed consent

You may not qualify if:

  • Severe chronic pulmonary disease
  • Refusal to participate
  • Missing intraoperative ventilatory data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos. Prof

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

March 20, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03