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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04281589
Other study ID # dondum
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 7, 2019
Est. completion date January 23, 2020

Study information

Verified date February 2020
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 L. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 23, 2020
Est. primary completion date January 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Döndu¨ Genç Moralar Istanbul Istanbul, Turkey

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary P (a-ET) CO2 gradient 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. 120 minutes
Secondary Partial arterial oxygen pressure (PaO2) Partial arterial oxygen pressure (PaO2) were recorded from the arterial blood gas analysis 120 minutes
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