Our longstanding goal is to assess the clinical applicability of EIT in intubated and mechanically ventilated patients. We aim to observe changes in regional lung ventilation during alterations of mechanical ventilation strategies in clinical…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the change in regional lung aeration, assessed by
the electrical impedance tomography.
Secondary outcome
-
Background summary
Mechanical ventilation is mandatory in patients under general anesthesia.
Mechanical ventilation has the potential to aggravate or even initiate lung
injury, causing overdistention of the non-dependent lung regions and repetitive
collapse and re-expansion of dependent lung regions (e.g. atelectasis). Various
modesof mechanical ventilation are employed during general anesthesia for
surgery in an effort to minimize atalectasis and prevent lung injury caused by
mechanical ventilation.
Electrical Impedance tomography (EIT) is a real-time, non-invasive, bed-side,
radiation-free continuous imaging technique able to detect changes of regional
lung aeration that could be used to guide mechanical ventilation settings.
Study objective
Our longstanding goal is to assess the clinical applicability of EIT in
intubated and mechanically ventilated patients. We aim to observe changes in
regional lung ventilation during alterations of mechanical ventilation
strategies in clinical situations. EIT will be applied in existing
interventional trials in the operation room (e.g., PROVHILO; MEC 10/251),
assessing regional lung ventilation in non-injured lungs during the
interventions (see research protocol of PROVHILO). Moreover, the effects of
different strategies on regional lung ventilation in other patient populations
can be determined during mechanical ventilation strategies as performed
according to standard clinical care.
The main research questions include:
1. Technical feasibility of EIT registration during mechanically ventilation in
patients under general anesthesia for surgery.
2. Assessment of changes in regional lung aeration during mechanical
ventilation in the interventional trial PROVHILO (MEC 10/251), and future
trials comparing different ventilation strategies.
3. Assessment of changes in regional lung aeration during changes in mechanical
ventilation therapy according to standard clinical care.
4. Assessment of correlation of changes in regional lung aeration with observed
gas exchange and radiological assessments.
Study design
This study concerns non-invasive observations in intubated and mechanically
ventilated patients with non-injured lungs in the operation room.
This is a observational study; electrical impenance tomography will be used to
observe regional lung aeration changes during interventions in existing
interventional trials and in ventilation strategy changes according standard
clinical care.
Prior to EIT registration 16 electrocardiographic electrodes will be placed
around the thoracic cage at the 5th or 6th intercostal space and connected with
an EIT device. EIT data are generated using an electrical current of 5 mA at 50
kHz (equal to ECG registration).
As data analysis of the EIT registrations are presently performed off-line,
after the measurements, the ventilator settings applied by the clinician can
and will not be influenced.
Study burden and risks
In this observational study there are no risks involved for participating
patients. Patient burden is minimal to none, and comprises of painless
placement of an electrical impedance belt around the lower thorax
pre-operatively. The patient will not experience any burden of the
measurements.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Intubation and mechanical ventilation because of general anesthesia for surgery
Exclusion criteria
Age < 18 years
Presence of a pacemaker
Presence of an automatic cardiac defibrillator
Presence of any implantable pumps
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 |
---|---|
ISRCTN | ISRCTN70332574 |
CCMO | NL36684.018.11 |