AtelectasisNCT05873998
Detecting Lung's Closing Pressure by Capnography
An observational study of Atelectasis, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
General anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway. Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- Slow pressure-volume curve
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 28 Feb 2023to 10 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing general anesthesia for mediastinoscopy.
Who may be able to join
- Age > 17 years ole
- Programmed surgery
Who cannot join
- Pregnancy
- No programmed surgery
- Hemodynamic instability
- Severe COPD
- Acute respiratory infection
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Privado de Comunidad
Mar del Plata, Buenos Aires, 7600
About this study
Official title: Analysis of CO2/Volume and CO2-pressure Curves to Detect the Lung's Closing Pressure in Ventilated Patients
General anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway.
Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local inflammatory response in atelectatic lung areas known as ventilatory-induced lung injury. This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes them to hypoxemic episodes that can persist in the early postoperative period.
Lung recruitment maneuvers restore the functional residual capacity and, therefore, protect the lungs from lung injury. A key issue in this kind of treatment is detecting the lung's closing pressure in order to maintain the end-expiratory pressure above such a limit.
Read the detailed description
This is a prospective and observational study designed to measure the lung's closing pressure. The investigators will study 20 mechanically ventilated patients scheduled for mediastinoscopy surgery under general anesthesia.
Lung mechanics and capnography will be assessed during surgery. A slow pressure-volume curve will be automatically performed by the ventilator, and the small airway closing pressure will be determined as the inflection point in the alveolar slope of the pressure-CO2 and volume-CO2 curves. Then, a lung recruitment maneuver will be applied following a descending positive end-expiratory pressure trial to determine the lung's closing pressure. The investigator will see if the lung's closing pressure found with these two techniques is similar.
- Conditions
- Atelectasis
- Being tested
- Slow pressure-volume curve
- Keywords
- carbon dioxide, mechanical ventilation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow pressure-volume curveDiagnostic test
Also called Lung recruitment maneuver
Patients will be sequentially subjected to a slow pressure-volume curve and a lung recruitment maneuver
| Study group | Role | What they receive |
|---|---|---|
| Adults anesthetized patients undergoing mediastinoscopy | Determination of the lung's closing pressure by pressure-CO2 and volume-CO2 curves using a slow pressure-volume curve after anesthesia induction. Later on, a standard lung recruitment maneuver followed by a positive end-expiratory pressure trial was done to detect the lung's closing pressure. Receives: Diagnostic Test: Slow pressure-volume curve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway pressure
Airway pressure will be measured at the airways opening and expressed in cmH2O.
Measured: 30 minutes
Carbon dioxide
Expired carbon dioxide will be measured at the airways opening by a main-stream capnograph, expressed in mmHg.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start28 Feb 2023
- Primary completion1 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Privado de Comunidad de Mar del Plata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora Fuentes, PhD, Study chair, Hospital Privado de Comunidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873998
- Sponsor's protocol ID
- CP2023
- Status last verified
- May 2025
- First submitted
- 28 Feb 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of CO2/Volume and CO2-pressure Curves to Detect the Lung's Closing Pressure in Ventilated Patients
- ClinicalTrials.gov ID
- NCT05873998
- Acronym / sponsor ID
- CP2023
- Conditions
- Atelectasis
- Keywords
- carbon dioxide, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 24 May 2023 (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.
General anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway.
Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local inflammatory response in atelectatic lung areas known as ventilatory-induced lung injury. This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes them to hypoxemic episodes that can persist in the early postoperative period.
Lung recruitment maneuvers restore the functional residual capacity and, therefore, protect the lungs from lung injury. A key issue in this kind of treatment is detecting the lung's closing pressure in order to maintain the end-expiratory pressure above such a limit.
Detailed description
This is a prospective and observational study designed to measure the lung's closing pressure. The investigators will study 20 mechanically ventilated patients scheduled for mediastinoscopy surgery under general anesthesia.
Lung mechanics and capnography will be assessed during surgery. A slow pressure-volume curve will be automatically performed by the ventilator, and the small airway closing pressure will be determined as the inflection point in the alveolar slope of the pressure-CO2 and volume-CO2 curves. Then, a lung recruitment maneuver will be applied following a descending positive end-expiratory pressure trial to determine the lung's closing pressure. The investigator will see if the lung's closing pressure found with these two techniques is similar.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults anesthetized patients undergoing mediastinoscopy | – | Diagnostic Test: Slow pressure-volume curveDetermination of the lung's closing pressure by pressure-CO2 and volume-CO2 curves using a slow pressure-volume curve after anesthesia induction. Later on, a standard lung recruitment maneuver followed by a positive end-expiratory pressure trial was done to detect the lung's closing pressure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing general anesthesia for mediastinoscopy.
Key inclusion criteria (2 listed)
- Age > 17 years ole
- Programmed surgery
Key exclusion criteria (5 listed)
- Pregnancy
- No programmed surgery
- Hemodynamic instability
- Severe COPD
- Acute respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow pressure-volume curveAlso: Lung recruitment maneuverPatients will be sequentially subjected to a slow pressure-volume curve and a lung recruitment maneuver | Diagnostic test | Adults anesthetized patients undergoing mediastinoscopy |
Primary outcome
Airway pressure
Time frame: 30 minutes
Airway pressure will be measured at the airways opening and expressed in cmH2O.
Carbon dioxide
Time frame: 30 minutes
Expired carbon dioxide will be measured at the airways opening by a main-stream capnograph, expressed in mmHg.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nora Fuentes, PhD study chair
Hospital Privado de Comunidad
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 Atelectasis, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 16 May 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 Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Airway pressure (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.