End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation

NCT ID: NCT04281589

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2020-01-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilation End-Tidal Carbon Dioxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

sequential
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double

Study Groups

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Group 1

tidal volüm is 4 ml/kg

Group Type EXPERIMENTAL

if the ventilation parameter caused desaturation or hypercapnia we will change the parameter

Intervention Type OTHER

we will increased fi02

Group 2

tidal volüm is 6 ml/kg

Group Type EXPERIMENTAL

if the ventilation parameter caused desaturation or hypercapnia we will change the parameter

Intervention Type OTHER

we will increased fi02

Group 3

tidal volüm is 8 ml/kg

Group Type EXPERIMENTAL

if the ventilation parameter caused desaturation or hypercapnia we will change the parameter

Intervention Type OTHER

we will increased fi02

Group 4

tidal volüm is 10 ml/kg

Group Type EXPERIMENTAL

if the ventilation parameter caused desaturation or hypercapnia we will change the parameter

Intervention Type OTHER

we will increased fi02

Interventions

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if the ventilation parameter caused desaturation or hypercapnia we will change the parameter

we will increased fi02

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Döndü Genç Moralar

Istanbul, Istanbul, Turkey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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dondum

Identifier Type: -

Identifier Source: org_study_id

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