The overall aim is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation. The primary objective is to investigate the changes in regional lung stress…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in regional lung stress when switching from
controlled to assisted ventilation and until a successful or failed switch.
This will be derived from electrical impedance tomography (EIT) recordings by
computing the ventilation distribution (parameter reflecting lung and
ventilation inhomogeneity).
Secondary outcome
Secondary endpoints include other EIT-derived parameters, lung tissue
characteristics on PCCT scan, respiratory mechanics, breathing effort,
ventilator-free days, patient-ventilator interaction, gas exchange and
hemodynamics, and inflammatory biomarkers.
Background summary
A crucial milestone in the trajectory of the mechanically ventilated patient is
the switch from fully controlled mechanical ventilation to assisted
ventilation. During assisted ventilation, spontaneous breathing is resumed
while the ventilator assists respiration. This switch should be made as early
as feasible and safe, to limit the detrimental effects from prolonged
controlled ventilation and sedation. However, there is also indirect evidence
that excessive breathing effort during assisted ventilation may worsen lung
injury (P-SILI). There are no guidelines that address this important switch
moment. The current *trial-and-error* approach falls short of recognizing
individual variability because we cannot accurately estimate P-SILI risks.
Study objective
The overall aim is to unravel the (patho)physiological mechanisms and potential
clinical benefits of a pre-specified early switch from controlled to assisted
ventilation. The primary objective is to investigate the changes in regional
lung stress when switching from controlled to assisted ventilation.
Study design
Physiological intervention study.
Intervention
The treatment intervention is a pre-specified switch from controlled to
assisted ventilation when PaO2/FiO2 ratio reaches >= 200 mmHg.
Study burden and risks
This study could optimize the patient-specific mechanical ventilation
treatment. The criterion of when to switch to assisted ventilation is
well-considered and based on literature evidence, while not allowing the switch
to assisted ventilation yet in patients in whom spontaneous breathing is not
recommended. Limiting the time spend on controlled ventilation and with
excessive sedation could reduce the serious complications directly related to
(the duration of) mechanical ventilation, and is expected to accelerate the
weaning process for the individual patient. Risks for participation are low as
most procedures are also part of routine clinical care. Measurements include
advanced respiratory monitoring using EIT and esophageal manometry; both
techniques carry minimal risks and are commonly performed in this population.
The photon-counting computed tomography (PCCT) scan procedure involves certain
risks associated with patient transportation to the scanner facility and
radiation exposure. Nevertheless, this scan will not be conducted on patients
who are medically unstable for transportation. Importantly, the radiation dose
is comparable to that of CT angiography assessments, frequently performed on
ICU patients experiencing hypoxemic respiratory failure. Additionally, PCCT
enhances image resolution, thus offering improved diagnostic clarity. During
this phase of the study, patients are deeply sedated and on fully-controlled
ventilation, therefore no discomfort is expected. Benefit of this procedure is
that the scan will become available to the clinical team. There are no risks
related to the collection of biomarkers from breath condensate or blood (via
the indwelling line that is already present).
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
• At least 18 years old
• Written informed consent
• Mechanical ventilation via an endotracheal tube
• Acute hypoxemic respiratory failure with PaO2/FiO2 ratio < 200 mmHg
• Under continuous sedation with or without paralysis
Exclusion criteria
• Expected mechanical ventilation duration of <48 hours
• Pure COPD exacerbation
• Pre-existent respiratory muscle disease
• Contraindication to EIT monitoring (as per clinical protocol, e.g. burns,
pacemaker, thoracic wounds limiting electrode placement)
• Contra-indications to oesophageal manometry (as per clinical protocol, e.g.,
recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
• Known pregnancy
• Anticipating withdrawal of life support and/or shift to palliation as the
goal of care
In addition, we note if the patient has a known allergy to iodine contrast
agent for CT-scan (relative contra-indication; a different type of contrast
will be used, if needed).
As also detailed in the study protocol (section 8.3), study enrolment will take
place when the patient still has a PaO2/FiO2 ratio <200 mmHg (inclusion
criterion), allowing sufficient time for the patient*s representative to
consider study participation and for the study team to prepare study
procedures. Actual study measurements will start when the patient*s lung injury
is recovering, i.e., when PaO2/FiO2 ratio reaches to 200 mmHg and when no new
exclusion criteria have developed. At that time, we check for the following
additional exclusion criteria:
• Need for extracorporeal membrane oxygenation (ECMO) therapy
• Hemodynamic instability (mean arterial pressure < 60 mmHg despite high dose
vasopressors (>0.5 gamma) and/or fluids, and/or heart rate < 55 bpm)
At any time, the treating physician may refuse study inclusion without further
explanation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85866.078.23 |