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Completed

NCT Number: NCT05827640

Expiratory Time Constant in Mechanically Ventilated Patients

Determining expiratory time constants in mechanically ventilated patients

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Slovak Institute for Cardiovascular Diseases

Košice, 040 01, Slovakia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

cardiac surgery with extracorporeal circulation

-

Exclusion criteria

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

Treatment and study plan

data recording using conventional ventilation strategies (PCV and VCV)

Other

no intervention

Primary outcomes

  1. Expiratory time constant

    Time frame: 3 months

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

Secondary outcomes

  1. Validity of expiratory time constant definition

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

East Slovak Institute for Cardiovascular Diseases

Other

Registry information

Official study title

Determining Expiratory Time Constant in Mechanically Ventilated Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.