Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax

January 17, 2025 updated by: Hospital Clinic of Barcelona
The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP without capnothorax. PEEP requirement and lung mechanics without capnothorax will be compared with a historical cohort population of robotic surgery with capnothorax.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08036
        • Hospital Clinic Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving uniportal robotic assisted lung resection with no capnothorax

Description

Inclusion Criteria:

  • Patients undergoing uniportal robotic lung resection under no capnothorax

Exclusion Criteria:

  • Refusal to participate
  • Contraindications to recruitment maneuvers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
URATS: Robotic lung surgery with no capnothorax
Uniportal robotic lung resection under no capnothorax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory airway pressures
Time Frame: During intra-operative mechanical ventilation (4 hours)
Respiratory airway pressures (peak pressure, plateau pressure and PEEP in cmH2O)
During intra-operative mechanical ventilation (4 hours)
Respiratory rate
Time Frame: During intra-operative mechanical ventilation (4 hours)
Respiratory rate (in cycles per minute)
During intra-operative mechanical ventilation (4 hours)
Respiratory system compliance
Time Frame: During intra-operative mechanical ventilation (4 hours)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gas parameters: pO2
Time Frame: During intra-operative mechanical ventilation (4 hours)
pO2 in mmHg in arterial blood gas sample
During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: pCO2
Time Frame: During intra-operative mechanical ventilation (4 hours)
pCO2 in mmHg in arterial blood gas sample
During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: pH
Time Frame: During intra-operative mechanical ventilation (4 hours)
pH of arterial blood gas samples (no unit can be applied)
During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: sodium bicarbonate
Time Frame: During intra-operative mechanical ventilation (4 hours)
Arterial blood sample sodium bicarbonate concentration (in mmol/L)
During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: base excess
Time Frame: During intra-operative mechanical ventilation (4 hours)
Base excess in arterial blood gas samples in mEq/L
During intra-operative mechanical ventilation (4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2024/0103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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