NCT03932617

Brief Summary

This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

April 28, 2019

Last Update Submit

February 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of sensitivity and specificity of end tidal carbon dioxide monitoring in predicting fluid responsiveness in correlation with stoke volume variation detected by cardiometry

    24 hour

Study Arms (2)

fluid responders

Device: end tidal carbon dioxide by capnography

fluid non responders

Device: end tidal carbon dioxide by capnography

Interventions

Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO. Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states.

fluid non respondersfluid responders

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tanta University Hospital at surgical intensive care unit (SICU).

You may qualify if:

  • Patients who will be 18 years or older.
  • Patients on mechanical ventilation in the intensive care.
  • Patients developing hypotension (MABP) \<65 mmHg.

You may not qualify if:

  • Patients with organ/s failure at presentation.
  • Patients with deep venous thrombosis.
  • Patients with limb and pelvic fractures.
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, Egypt

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 28, 2019

First Posted

May 1, 2019

Study Start

June 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 31, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations