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An assessment of the correlation between the consciousness state of mechanically ventilated sedated intensive care patients during the weaning phase from the ventilator and the quality and quantity of respiratory effort

An assessment of the correlation between the consciousness state of mechanically ventilated sedated intensive care patients during the weaning phase from the ventilator and the quality and quantity of respiratory effort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033394
Enrollment
100
Registered
2024-01-18
Start date
2022-11-05
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

2) Long-term ventilated patients with respiratory failure (ARDS)

Interventions

Group 1: Two formally distinct groups of mechanically ventilated intensive care patients are eligible for study inclusion: I. Patients who, on our intensive care unit (UMG, Station 0119), are long-ter

Sponsors

Universitätsmedizin Göttingen, Klinik für Anästheisologie & Klinik für Neurologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 91 Years

Inclusion criteria

Inclusion criteria: Female and male mechanically ventilated intensive care patients

Exclusion criteria

Exclusion criteria: Age 91 years - Refusal to participate in the study - No existing consent

Design outcomes

Primary

MeasureTime frame
The goal of this observational study is to establish a correlation between the consciousness state/sedation depth (in terms of an absolute numerical EEG oscillation frequency value or processed EEG) of mechanically ventilated intensive care patients during the weaning phase from the ventilator and the quality and quantity of respiratory effort. The below-listed data and measurement methods are recorded during the course of ventilation and/or sedation in the intensive care unit. Measurement instruments/parameters for sedation: -NarcotrendR, Massimo Root® with SedLine®, or BIS monitoring measured numerical absolute EEG value of EEG oscillation frequency (corresponding to sedation depth/consciousness state) -Sedative medications -Other Monitoring Parameters Measurement instruments/parameters for the ventilator (SERVO-U®): -Respiratory rate (RR) -Ratio of Tidal Volume (tV)/Ideal Tidal Volume (itV) -Additional ventilation parameters (minute volume, FiO2, PIP, PEEP, PS (Delta), airway occlusion pressure (P0.1), NAVA level, etc.) -Other parameters from the Ventilator -Breathing pattern (clinical assessment) Specific data Cumulative sedation dose, sedation depth, regional oxygen saturation, arterial oxygen concentrations, arterial carbon dioxide concentrations, arterial pH values, blood glucose levels, cumulative dose of glucose administration, JH-ACE, IQCODE, CAM-ICU, RASS (Richmond Agitation-Sedation Scale), possibly additional routinely collected parameters from arterial blood gas analysis.

Secondary

MeasureTime frame
Demographic data, age at study enrollment, gender, admission diagnosis, primary diagnoses, pre-existing conditions, comorbidities, SAPS II at admission, SOFA score, in the case of ARDS severity, duration of invasive ventilation, length of stay in the ICU, hospital length of stay, hospital mortality, ICU mortality, possibly additional routinely collected parameters.

Countries

Germany

Contacts

Public ContactIvan Chakalov

Universitätsmedizin Göttingen, Klinik für Anästheisologie & Klinik für Neurologie

ivan.chakalov@med.uni-goettingen.de0551/3967480

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026