End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation

NCT04281589 | Completed

• 1 other identifier: dondum
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilation; End-Tidal Carbon Dioxide

Keywords

End-Tidal Carbon Dioxide; P(a-ET)CO2 gradient; ETCO2; low tidal volüm; mekanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Partial arterial oxygen pressure (PaO2)

  120 minutes

Study Arms (4)

Group 1

EXPERIMENTAL

tidal volüm is 4 ml/kg

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

Group 2

EXPERIMENTAL

tidal volüm is 6 ml/kg

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

Group 3

EXPERIMENTAL

tidal volüm is 8 ml/kg

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

Group 4

EXPERIMENTAL

tidal volüm is 10 ml/kg

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

Interventions

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

we will increased fi02

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cardiac disease
• Pulmonary disease
• Obese patients

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Döndü Genç Moralar

Istanbul, Istanbul, Turkey, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: sequential

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 24, 2020
• Study Start: May 7, 2019
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)