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CompletedNCT05827640Updated Apr 25, 2023

Expiratory Time Constant in Mechanically Ventilated Patients

An observational study in Comparing Six Different Methods to Obtain Expiratory Time Constant, sponsored by East Slovak Institute for Cardiovascular Diseases. Completed at 1 site in Slovakia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by East Slovak Institute for Cardiovascular Diseases · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

Determining expiratory time constants in mechanically ventilated patients

Read the detailed description

Adult patients (n = 30) undergoing elective cardiac surgery with extracorporeal circulation (ECC) were included. Patients were excluded from the study if they had any known lung disease or had previous thoracic surgery. After the surgery, all patients were transferred to the intensive care unit (ICU) and connected to well-established Servo-U (Maquet, Getinge AB, Solna, Sweden) mechanical ventilator. First, the ventilation mode was set to mandatory volume-controlled ventilation (VCV) for 15 minutes. After that, mandatory pressure-controlled ventilation (PCV) for another 15 minutes was commenced. All patients were in supine position, sedated and paralyzed using continuous infusion of propofol and atracurium with no spontaneous breathing efforts. During VCV, an end-inspiratory pause (TPAUSE 10%) has been added to obtain inspiratory plateau pressure (P PLAT) under static conditions. Respiratory variables in VCV for all patients were as follows: PEEP 6 - 9 cmH 2 O depending on the local protocol, protective tidal volume (Vt) of 7 ml/kg/PBW, T PAUSE was set to 10%, I:E ratio of 1:2, rise time 5% and the respiratory rate was 14 breaths/min. After 15 minutes, VCV was changed to PCV with the same ventilator setting with inspiratory pressure set in the way to best match the Vt during the VCV. ARDSNet tables were used to determine PBW for all patients.

A novel device enabling data acquisition (Dr. Wave, Quadrus Medical Technologies, NY, White Plains, USA) has been connected to the Servo-U ventilator after admission to the ICU to record flow, pressure, and volume waveforms. All data in the study were derived from measurements and calculations from this device and included: Peak Inspiratory Pressure (PIP), PPLAT, PEEP, expiratory tidal volume (Vt) respiratory system compliance (C RS ), airway resistance (RTOT) and the peak expiratory flow rate (PEFR).

Based on obtained data of flow, volume and pressure during PCV and VCV, six different methods to determined expiratory time constant were examined

02

Conditions studied

  • Comparing Six Different Methods to Obtain Expiratory Time Constant

Keywords

  • expiratory time constant, mechanical ventilation, exhalation
03

In context

Lead sponsor

East Slovak Institute for Cardiovascular Diseases is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing elective cardiac surgery with extracorporeal circulation (mostly CABG or AVR).

Eligibility criteria

Inclusion Criteria: cardiac surgery with extracorporeal circulation

-

Exclusion Criteria:

  • known pulmonary disease
  • previous thoracic surgery
  • poor preoperative cardiac status
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • Otherdata recording using conventional ventilation strategies (PCV and VCV)

    no intervention

06

What researchers measure

Primary outcomes

  1. Expiratory time constant

    Six different methods to assess expiratory time constants in mechanically ventilated patients

    Time frame: 3 months

Secondary outcomes

  1. Validity of expiratory time constant definition

    To prove if three time constant correspond to actual first time constant multiplied by the factor of 3

    Time frame: 3 months

07

Study locations

1 site
  • East Slovak Institute for Cardiovascular Diseases
    Košice, 040 01, Slovakia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05827640
Lead sponsor
East Slovak Institute for Cardiovascular Diseases
Responsible party
Filip Depta MD (MD, East Slovak Institute for Cardiovascular Diseases) — Principal investigator
First posted
Apr 25, 2023
Start date
Nov 15, 2022
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023
Last update
Apr 25, 2023

Study contacts

Dušan Rybár, PhD
study director · East Slovak Institute for Cardiovascular Diseases

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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