Respiratory Physiological PhenomenaNCT03693352
Functional Residual Capacity Measured by Capnography in Ventilated Patients
An observational study of Respiratory Physiological Phenomena, run by Hospital Privado de Comunidad de Mar del Plata at 1 site in Argentina.
Trial summary
Changes in body position during anesthesia can alter functional residual capacity and gas exchange. The monitoring of such changes in functional residual capacity is difficult at the bedside. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Respiratory Physiological Phenomena
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2018to 1 Apr 2020
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing general anesthesia for laparoscopic surgery
Who may be able to join
- Written Inform Consent
- Programmed surgery
- Laparoscopic surgery
- Supine position
Who cannot join
- Emergency surgery
- Chronic respiratory disease
- Active smoking
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: Effect of Positive End-expiratory Pressure on Functional Residual Capacity Measured by Volumetric Capnography in Mechanically Ventilated Patients
Changes in body position during anesthesia can alter functional residual capacity and gas exchange. The monitoring of such changes in functional residual capacity is difficult at the bedside. The present study was designed to determine if volumetric capnography can detect changes in the functional residual capacity during surgery.
Read the detailed description
This is a prospective and observational study designed to test the reliability of the capnodynamic equation to determine changes in functional residual capacity measured during anesthesia. The investigators will studied 40 mechanically ventilated patients undergoing general anesthesia. Functional residual capacity will be continuously measured in a non invasive way using expired carbon dioxide. Changes in functional residual capacity with standard modification in body positioning (Trendelenburg or anti-Trendelenburg position) and ventilatory settings wiil be tested.
- Conditions
- Respiratory Physiological Phenomena
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 |
|---|---|---|
| Patients undergoing surgeries | Patients ASA 1-3, undergoing different types of general anesthesia that need postural changes like Trendelenburg and anti-Trendelenburg positioning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Residual Capacity Measured by Capnography in Ventilated Patients
Measurement of functional residual capacity with capnography with body positioning changes.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start1 Oct 2018
- Primary completion10 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Physiological PhenomenaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 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
- Gerardo Tusman, MD, Principal investigator, Hospital Privado de Comunidad de Mar del Plata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693352
- Sponsor's protocol ID
- 2919/1728/18
- Status last verified
- Feb 2020
- First submitted
- 1 Oct 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Albu G, Wallin M, Hallback M, Emtell P, Wolf A, Lonnqvist PA, Gothberg S, Petak F, Habre W. Comparison of static end-expiratory and effective lung volumes for gas exchange in healthy and surfactant-depleted lungs. Anesthesiology. 2013 Jul;119(1):101-10. doi: 10.1097/ALN.0b013e3182923c40.
PubMed 23571638Tusman G, Wallin M, Acosta C, Santanera B, Portela F, Viotti F, Fuentes N, Hallback M, Suarez-Sipmann F. Positive end-expiratory pressure individualization guided by continuous end-expiratory lung volume monitoring during laparoscopic surgery. J Clin Monit Comput. 2022 Oct;36(5):1557-1567. doi: 10.1007/s10877-021-00800-2. Epub 2021 Dec 29.
PubMed 34966951
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End-expiratory Pressure on Functional Residual Capacity Measured by Volumetric Capnography in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03693352
- Acronym / sponsor ID
- 2919/1728/18
- Conditions
- Respiratory Physiological Phenomena
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Privado de Comunidad de Mar del PlataUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 3 Oct 2018 (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.
Changes in body position during anesthesia can alter functional residual capacity and gas exchange. The monitoring of such changes in functional residual capacity is difficult at the bedside. The present study was designed to determine if volumetric capnography can detect changes in the functional residual capacity during surgery.
Detailed description
This is a prospective and observational study designed to test the reliability of the capnodynamic equation to determine changes in functional residual capacity measured during anesthesia. The investigators will studied 40 mechanically ventilated patients undergoing general anesthesia. Functional residual capacity will be continuously measured in a non invasive way using expired carbon dioxide. Changes in functional residual capacity with standard modification in body positioning (Trendelenburg or anti-Trendelenburg position) and ventilatory settings wiil be tested.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing surgeries | – | –Patients ASA 1-3, undergoing different types of general anesthesia that need postural changes like Trendelenburg and anti-Trendelenburg positioning. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing general anesthesia for laparoscopic surgery
Key inclusion criteria (4 listed)
- Written Inform Consent
- Programmed surgery
- Laparoscopic surgery
- Supine position
Key exclusion criteria (3 listed)
- Emergency surgery
- Chronic respiratory disease
- Active smoking
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
Functional Residual Capacity Measured by Capnography in Ventilated Patients
Time frame: 6 hours
Measurement of functional residual capacity with capnography with body positioning changes.
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 14 Jul 2020.
- Background: PubMed 23571638Albu G, Wallin M, Hallback M, Emtell P, Wolf A, Lonnqvist PA, Gothberg S, Petak F, Habre W. Comparison of static end-expiratory and effective lung volumes for gas exchange in healthy and surfactant-depleted lungs. Anesthesiology. 2013 Jul;119(1):101-10. doi: 10.1097/ALN.0b013e3182923c40.
- Derived from this study: PubMed 34966951Tusman G, Wallin M, Acosta C, Santanera B, Portela F, Viotti F, Fuentes N, Hallback M, Suarez-Sipmann F. Positive end-expiratory pressure individualization guided by continuous end-expiratory lung volume monitoring during laparoscopic surgery. J Clin Monit Comput. 2022 Oct;36(5):1557-1567. doi: 10.1007/s10877-021-00800-2. Epub 2021 Dec 29.
- 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.
Gerardo Tusman, MD principal investigator
Hospital Privado de Comunidad de Mar del Plata
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 Respiratory Physiological Phenomena, 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 4 inclusion and 3 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 14 Jul 2020. 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?
Functional Residual Capacity Measured by Capnography in Ventilated Patients (time frame: 6 hours). 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 NCT03693352, which also lists 2 linked publications.
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 14 Jul 2020.