Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

GapCO2 and Respiratory Rate in Patients Under Volume Mechanical Ventilation (gapCO2)

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: NCT02867943
Recruitment Status : Unknown
Verified August 2016 by 105 Hospital of Chinese People's Liberation Army.
Recruitment status was:  Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
105 Hospital of Chinese People's Liberation Army

Tracking Information
First Submitted Date August 11, 2016
First Posted Date August 16, 2016
Last Update Posted Date August 18, 2016
Study Start Date October 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2016)
Effects of respiratory rate on venous-to-arterial CO2 tension difference in septic shock patients Under Volume Mechanical Ventilation [ Time Frame: 1 year ]
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 GapCO2 and Respiratory Rate in Patients Under Volume Mechanical Ventilation
Official Title Effects of Respiratory Rate on Venous-to-arterial CO2 Tension Difference in Septic Shock Patients Under Volume Mechanical Ventilation
Brief Summary As an approximate of the difference between venous-to-arterial CO2 tension (∆PCO2), ∆PCO2 is proportional to CO2 production and inversely related to cardiac output (Fick equation). Anaerobic CO2 production is thought to occur when tissue hypoxia is present, mostly because of buffering of bicarbonate ions by the protons produced in excess secondary to the hydrolysis of adenosine triphosphate. Therefore ∆PCO2 has been proposed as a marker of tissue hypoxia.
Detailed Description

An increased ∆PCO2 (> 6 mmHg) could be used to identify patients who still remain inadequately resuscitated, when deciding when to continue resuscitation despite a central venous oxygen saturation (ScvO2) > 70% associated with elevated blood lactate levels.

Under steady states of both VO2 and VCO2, P (v-a) CO2 was observed to increase in parallel with the reduction in cardiac output. However, spontaneous breathing and hyperventilation may reduce PaCO2 and prevent the CO2 stagnation-induced rise in PvCO2.

To date,these studies of ∆PCO2 and respiratory rate in septic shock patients Under Volume Mechanical Ventilation are rarely.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The subjects were sequentially admitted to the Department of Critical Care Medicine of 105 Hospital of PLA from March of 2016 till the end of this study.
Condition Shock
Intervention Other: Effects of respiratory rate on gapCO2
respiratory rate was started at 10 breaths/min and added by 2 breaths/min every 60 min up to 16 breaths/min
Study Groups/Cohorts
  • respiratory rate is 10 breaths/min

    GapCO2=Pv-aCO2 = PvCO2 - PaCO2;

    Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

    Intervention: Other: Effects of respiratory rate on gapCO2
  • respiratory rate is 12 breaths/min

    GapCO2=Pv-aCO2 = PvCO2 - PaCO2;

    Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

    Intervention: Other: Effects of respiratory rate on gapCO2
  • respiratory rate is 14 breaths/min

    GapCO2=Pv-aCO2 = PvCO2 - PaCO2;

    Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

    Intervention: Other: Effects of respiratory rate on gapCO2
  • respiratory rate is 16 breaths/min

    GapCO2=Pv-aCO2 = PvCO2 - PaCO2;

    Effects of venous-to-arterial CO2 tension difference after increased respiratory rate.

    Intervention: Other: Effects of respiratory rate on gapCO2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 11, 2016)
28
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients were included in the study, if the attending physician find the persistence of signs of hypoperfusion (oliguria, mottled skin, central venous oxygen saturation (ScvO2) <70 % despite a hemoglobin > 8 g/dl),despite achieving adequate intravascular volume and adequate mean arterial pressure (MAP) > 65 mmHg as recommended by the Surviving Sepsis Campaign.

Exclusion Criteria:

Exclusion criteria were pregnancy, COPD,age less than 18 years old, unstable hemodynamic condition (change of vasoactive drug dosage or fluid administration within 1 h preceding the protocol) and uncontrolled tachyarrhythmias (heart rate>140 beats/min).

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02867943
Other Study ID Numbers PLA-105-ICU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party 105 Hospital of Chinese People's Liberation Army
Study Sponsor 105 Hospital of Chinese People's Liberation Army
Collaborators Not Provided
Investigators Not Provided
PRS Account 105 Hospital of Chinese People's Liberation Army
Verification Date August 2016