ETCO2: End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04281589
Collaborator
(none)
50
1
4
8.6
5.8

Study Details

Study Description

Brief Summary

In cases where there is no ventilation-perfusion problem, the end-tidal carbon dioxide (ETCO2) value is closely associated with partial arterial carbon dioxide pressure (PaCO2); therefore, the PaCO2 value can be estimated using ETCO2 measurements in patients without significant cardiopulmonary disorders. The aim of the investigator's study is to evaluate the reliability of pulmonary ventilation monitoring with ETCO2 value and to investigate at what tidal volume values ETCO2 monitoring provides reliable information.

Condition or Disease Intervention/Treatment Phase
  • Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
N/A

Detailed Description

The patients were grouped as follows: Group 1, if the tidal volume is 4 ml/kg; Group 2, if TV=6 ml/kg; Group 3, if TV=8 ml/kg; and Group 4, if TV=10 ml/kg. It was determined how many breaths per minute (minute ventilation) would be given with tidal volume x respiratory rate=6

  1. The patients were ventilated with the same ventilation parameters for 30 minutes and then arterial blood gas analysis was performed. Arterial blood gas was collected at t1 for group 1, t2 for group 2, t3 for group 3, and t4 for group 4. The ETCO2 value, Peak pressure (Ppeak), Plateau pressure (Pplato), mean airway pressure (Pmean) values were recorded at the time of arterial blood gas collection. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peak heart rate (PHR) values were evaluated. The patients with a mean arterial pressure of less than 65 mmHg were excluded from the study. Partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2), oxygen saturation (SO2) values were recorded from the arterial blood gas analysis. P (a-ET) CO2 gradient value was calculated.

The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaO2 values and hence the P (a-ET) CO2 gradient changed.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
sequentialsequential
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Double
Primary Purpose:
Other
Official Title:
Does End-Tidal Carbon Dioxide Value Show The Adequacy Of Ventilation In Low Tidal Volume Ventilation
Actual Study Start Date :
May 7, 2019
Actual Primary Completion Date :
Jan 23, 2020
Actual Study Completion Date :
Jan 23, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

tidal volüm is 4 ml/kg

Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
we will increased fi02

Experimental: Group 2

tidal volüm is 6 ml/kg

Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
we will increased fi02

Experimental: Group 3

tidal volüm is 8 ml/kg

Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
we will increased fi02

Experimental: Group 4

tidal volüm is 10 ml/kg

Other: if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
we will increased fi02

Outcome Measures

Primary Outcome Measures

  1. P (a-ET) CO2 gradient [120 minutes]

    The groups were compared, in each patient, under the same conditions, when the different tidal volume was applied, how the ETCO2 monitorization, PaCO2 values and hence the P (a-ET) CO2 gradient changed.

Secondary Outcome Measures

  1. Partial arterial oxygen pressure (PaO2) [120 minutes]

    Partial arterial oxygen pressure (PaO2) were recorded from the arterial blood gas analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

American Society of Anesthesiologists (ASA) classification 1, 2 risk group

Head and neck surgery under general anesthesia lasting more than 120 minutes and who progressed normotensive.

Exclusion Criteria:

Cardiac disease

Pulmonary disease

Obese patients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Döndü Genç Moralar Istanbul Istanbul, Turkey Turkey 34000

Sponsors and Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT04281589
Other Study ID Numbers:
  • dondum
First Posted:
Feb 24, 2020
Last Update Posted:
Feb 24, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Results

No Results Posted as of Feb 24, 2020