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Functional Residual Capacity Measured by Capnography in Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693352
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Privado de Comunidad de Mar del Plata

Tracking Information
First Submitted Date October 1, 2018
First Posted Date October 3, 2018
Last Update Posted Date July 14, 2020
Actual Study Start Date October 1, 2018
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 1, 2018)
Functional Residual Capacity Measured by Capnography in Ventilated Patients [ Time Frame: 6 hours ]
Measurement of functional residual capacity with capnography with body positioning changes.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Residual Capacity Measured by Capnography in Ventilated Patients
Official Title Effect of Positive End-expiratory Pressure on Functional Residual Capacity Measured by Volumetric Capnography in Mechanically Ventilated Patients
Brief 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. 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing general anesthesia for laparoscopic surgery
Condition Respiratory Physiological Phenomena
Intervention Not Provided
Study Groups/Cohorts Patients undergoing surgeries
Patients ASA 1-3, undergoing different types of general anesthesia that need postural changes like Trendelenburg and anti-Trendelenburg positioning.
Publications * Albu G, Wallin M, Hallbäck M, Emtell P, Wolf A, Lönnqvist PA, Göthberg S, Peták 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 1, 2018)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date April 1, 2020
Actual Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Written Inform Consent
  • Programmed surgery
  • Laparoscopic surgery
  • Supine position

Exclusion Criteria:

  • Emergency surgery
  • Chronic respiratory disease
  • Active smoking
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT03693352
Other Study ID Numbers 2919/1728/18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospital Privado de Comunidad de Mar del Plata
Study Sponsor Hospital Privado de Comunidad de Mar del Plata
Collaborators Not Provided
Investigators
Principal Investigator: Gerardo Tusman, MD Hospital Privado de Comunidad de Mar del Plata
PRS Account Hospital Privado de Comunidad de Mar del Plata
Verification Date February 2020