- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693352
Functional Residual Capacity Measured by Capnography in Ventilated Patients
July 13, 2020 updated by: Hospital Privado de Comunidad de Mar del Plata
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
40
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
-
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, 7600
- Hospital Privado de Comunidad
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-
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
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing general anesthesia for laparoscopic surgery
Description
Inclusion Criteria:
- Written Inform Consent
- Programmed surgery
- Laparoscopic surgery
- Supine position
Exclusion Criteria:
- Emergency surgery
- Chronic respiratory disease
- Active smoking
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Patients undergoing surgeries
Patients ASA 1-3, undergoing different types of general anesthesia that need postural changes like Trendelenburg and anti-Trendelenburg positioning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Residual Capacity Measured by Capnography in Ventilated Patients
Time Frame: 6 hours
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Measurement of functional residual capacity with capnography with body positioning changes.
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gerardo Tusman, MD, Hospital Privado de Comunidad de Mar del Plata
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tusman G, Wallin M, Acosta C, Santanera B, Portela F, Viotti F, Fuentes N, Hallbäck 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.
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)
October 1, 2018
Primary Completion (Actual)
February 10, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
October 1, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 3, 2018
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2919/1728/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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