NCT06784037

Brief Summary

The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Start

First participant enrolled

February 16, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 20, 2025

Status Verified

December 1, 2024

Enrollment Period

1.9 years

First QC Date

December 16, 2024

Last Update Submit

January 17, 2025

Conditions

Keywords

robotic lung surgeryPEEPcapnothorax

Outcome Measures

Primary Outcomes (3)

  • Respiratory airway pressures

    Respiratory airway pressures (peak pressure, plateau pressure and PEEP in cmH2O)

    During intra-operative mechanical ventilation (4 hours)

  • Respiratory rate

    Respiratory rate (in cycles per minute)

    During intra-operative mechanical ventilation (4 hours)

  • Respiratory system compliance

    Respiratory pressures measurement will be combined to obtain respiratory system compliance. Respiratory system compliance = (plateau pressure-PEEP) / respiratory tidal volume (expressed in cmH2O/mL)

    During intra-operative mechanical ventilation (4 hours)

Secondary Outcomes (5)

  • Arterial blood gas parameters: pO2

    During intra-operative mechanical ventilation (4 hours)

  • Arterial blood gas parameters: pCO2

    During intra-operative mechanical ventilation (4 hours)

  • Arterial blood gas parameters: pH

    During intra-operative mechanical ventilation (4 hours)

  • Arterial blood gas parameters: sodium bicarbonate

    During intra-operative mechanical ventilation (4 hours)

  • Arterial blood gas parameters: base excess

    During intra-operative mechanical ventilation (4 hours)

Study Arms (1)

URATS: Robotic lung surgery with no capnothorax

Uniportal robotic lung resection under no capnothorax

Eligibility Criteria

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

Patients receiving uniportal robotic assisted lung resection with no capnothorax

You may qualify if:

  • Patients undergoing uniportal robotic lung resection under no capnothorax

You may not qualify if:

  • Refusal to participate
  • Contraindications to recruitment maneuvers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

January 20, 2025

Study Start

February 16, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 20, 2025

Record last verified: 2024-12

Locations