Functional Residual Capacity Measured by Capnography in Ventilated Patients

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

Functional Residual Capacity Measured by Capnography in Ventilated Patients

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

: Patients undergoing surgeries
Patients ASA 1-3, undergoing different types of general anesthesia that need postural changes like Trendelenburg and anti-Trendelenburg positioning.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 2019

Estimated Primary Completion Date

May 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Argentina

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Hospital Privado de Comunidad de Mar del Plata

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Gerardo Tusman, MD Hospital Privado de Comunidad de Mar del Plata

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名