The Value of Central Venous-arterial Carbon Dioxide Difference

February 17, 2021 updated by: Liang Bing

A Research of Central Venous-arterial Carbon Dioxide Difference Has Guiding Significance for Severely Burn Patients in Liquid Resuscitation During Early Escharectomy

By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: By observing the changes of Central venous-arterial partial pressure difference of carbon dioxide [P (v-a) CO2] in liquid resuscitation during early escharectomy in patients with large-scale burns, We investigate the effect of P (v-a) CO2 on postoperative tissue perfusion and oxygenation in order to seek a more effective intergrated target plan of liquid resuscitation for burn patients.

Methods: a prospective observational study was conducted on 145 patients with extensive burns admitted to surgical intensive care unit（SICU）of Guangzhou Red Cross hospital from January 2016 to December 2019. All patients received hemodynamic monitoring and goal-directed fluid therapy, patients with central venous oxygen saturation (ScvO2)< 70% were excluded. Patients were divided into the following groups according to the changing trend of Pcv-aCO2 between T base (before induction) and T 0h (after surgery) : group 1 (H-H) : Pcv-aCO2≥6mmHg between T base and T 0h. Group 2 (L-H) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h; Group 3 (H-L) : Pcv-aCO2≥6mmHg at T base and < 6mmHg at T 0h. Group 4( L-L) : Pcv-aCO2 < 6mmHg between T base and T0h.Postoperative basic physiological indicators such as heart rate（HR）, blood pressure, central venous pressure (CVP), cardiac output index (CI), Pcv-aCO2 and lactic acid were recorded at 0 and 18 hours after surgery. Oxygen dynamic indicators such as oxygen delivery index (DO2I), oxygen consumption index (VO2I), oxygen uptake rate (O2ER) and so on were calculated. Pearson correlation analysis was used to evaluate the correlation between Pcv-aCO2 and CI. The change of tissue perfusion and oxygenation with different levels of Pcv-aCO2 after fluid resuscitation were analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASAI-II
  2. New York Heart Association classification of cardiac function I-II
  3. Estimated time of operation<3h
  4. The circulatory system of patients is stable after thrapy：CVP8～12 mmHg；MAP≥65 mmHg；urine volume>0.5m1/kg/ h；ScvO2：≥70％。

Exclusion Criteria:

  1. Anesthetic drug allergy or contraindication
  2. Patients with cardiopulmonary system disease、cardiopulmonary function abnormality、severe inhalation injuryand severe visceral injury.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group 1
(H-P) : Pcv-aCO2≥6mmHg between T base and T 0h.;
Drug: Goal-directed fluid therapy (GDET)
Compensatory dilatation was performed firstly and 5ml/kg crystal solution was added within 30min before induction of anesthesia.When SVV≥13%, infusion of colloidal solution 2ml/kg was performed 15-20 minutes.If the increase of SV was≥10% after the liquid impact and the SVV was still≥13%, the colloidal solution was used again for 2mL/kg and the infusion was maintained until the SVV < 13%.The infusion was stopped when the SVV < 10%.If the increase of SV was less than 10% or CI < 2.0L/min/m2 after infusion, dobutamine was given intravenously to observe the change of SV. If the increase of SV was greater than 10%, dobutamine could be maintained and the above fluid regimen continued.If the increase of SV was less than 10% and MAP≥65mmHg, the infusion of liquid was stopped and replaced with 4ml/kg/h infusion for maintenance.If the increase of SV was less than 10% and MAP was less than 65mmHg, the infusion was suspended.
EXPERIMENTAL: Group 2
(L-P) : Pcv-aco2< 6mmHg at T base and≥6mmHg at T 0h
Drug: Goal-directed fluid therapy (GDET)
Compensatory dilatation was performed firstly and 5ml/kg crystal solution was added within 30min before induction of anesthesia.When SVV≥13%, infusion of colloidal solution 2ml/kg was performed 15-20 minutes.If the increase of SV was≥10% after the liquid impact and the SVV was still≥13%, the colloidal solution was used again for 2mL/kg and the infusion was maintained until the SVV < 13%.The infusion was stopped when the SVV < 10%.If the increase of SV was less than 10% or CI < 2.0L/min/m2 after infusion, dobutamine was given intravenously to observe the change of SV. If the increase of SV was greater than 10%, dobutamine could be maintained and the above fluid regimen continued.If the increase of SV was less than 10% and MAP≥65mmHg, the infusion of liquid was stopped and replaced with 4ml/kg/h infusion for maintenance.If the increase of SV was less than 10% and MAP was less than 65mmHg, the infusion was suspended.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Central venous oxygen saturation
Time Frame: From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Central venous oxygen saturation in venous blood
From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Lactic acid value
Time Frame: From start anesthesia until end of anesthesia, up to a maximum of 6 hours
Lactic acid level in arterial blood
From start anesthesia until end of anesthesia, up to a maximum of 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liang Bing

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-047-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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