Robotic Thoracic SurgeryNCT06784037
Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax
An observational study of Robotic Thoracic Surgery and Mechanical Ventilation, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robotic Thoracic Surgery, Mechanical Ventilation, Positive End Expiratory Pressure (PEEP)
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Feb 2024to 31 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving uniportal robotic assisted lung resection with no capnothorax
Who may be able to join
- Patients undergoing uniportal robotic lung resection under no capnothorax
Who cannot join
- Refusal to participate
- Contraindications to recruitment maneuvers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.
Read the 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.
- Keywords
- robotic lung surgery, PEEP, capnothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| URATS: Robotic lung surgery with no capnothorax | Uniportal robotic lung resection under no capnothorax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory airway pressures
Respiratory airway pressures (peak pressure, plateau pressure and PEEP in cmH2O)
Measured: During intra-operative mechanical ventilation (4 hours)
Respiratory rate
Respiratory rate (in cycles per minute)
Measured: 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)
Measured: During intra-operative mechanical ventilation (4 hours)
Secondary outcomes (5)
Arterial blood gas parameters: pO2
pO2 in mmHg in arterial blood gas sample
Measured: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: pCO2
pCO2 in mmHg in arterial blood gas sample
Measured: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: pH
pH of arterial blood gas samples (no unit can be applied)
Measured: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: sodium bicarbonate
Arterial blood sample sodium bicarbonate concentration (in mmol/L)
Measured: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: base excess
Base excess in arterial blood gas samples in mEq/L
Measured: During intra-operative mechanical ventilation (4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Robotic Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784037
- Sponsor's protocol ID
- HCB/2024/0103
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Navarro-Ripoll R, Italiano S, Segui F, Bunuel A, Revuelta D, Lopez-Baamonde M, Urena A, Ramos R, Ferrando C. Impact on Respiratory Mechanics of Uniportal-Biportal Robotic Lung Resection Without Capnothorax Versus Multiportal Approach With Capnothorax: A Prospective Cohort Observational Study. Anesthesiol Res Pract. 2026 Oct 8;2026:5324693. doi: 10.1155/anrp/5324693. eCollection 2026.
PubMed 42852057
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax
- ClinicalTrials.gov ID
- NCT06784037
- Acronym / sponsor ID
- HCB/2024/0103
- Keywords
- robotic lung surgery, PEEP, capnothorax
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the impact on lung mechanics during robotic lung resection when no capnothorax is used.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| URATS: Robotic lung surgery with no capnothorax | – | –Uniportal robotic lung resection under no capnothorax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving uniportal robotic assisted lung resection with no capnothorax
Key inclusion criteria (1 listed)
- Patients undergoing uniportal robotic lung resection under no capnothorax
Key exclusion criteria (2 listed)
- Refusal to participate
- Contraindications to recruitment maneuvers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory airway pressures
Time frame: During intra-operative mechanical ventilation (4 hours)
Respiratory airway pressures (peak pressure, plateau pressure and PEEP in cmH2O)
Respiratory rate
Time frame: During intra-operative mechanical ventilation (4 hours)
Respiratory rate (in cycles per minute)
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)
5 secondary outcomes
Arterial blood gas parameters: pO2
Time frame: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: pCO2
Time frame: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: pH
Time frame: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: sodium bicarbonate
Time frame: During intra-operative mechanical ventilation (4 hours)
Arterial blood gas parameters: base excess
Time frame: During intra-operative mechanical ventilation (4 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Derived from this study: PubMed 42852057Navarro-Ripoll R, Italiano S, Segui F, Bunuel A, Revuelta D, Lopez-Baamonde M, Urena A, Ramos R, Ferrando C. Impact on Respiratory Mechanics of Uniportal-Biportal Robotic Lung Resection Without Capnothorax Versus Multiportal Approach With Capnothorax: A Prospective Cohort Observational Study. Anesthesiol Res Pract. 2026 Oct 8;2026:5324693. doi: 10.1155/anrp/5324693. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Thoracic Surgery and Mechanical Ventilation, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory airway pressures (time frame: During intra-operative mechanical ventilation (4 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06784037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.