The primary objective of this study is to compare the effect of a standard and early RM in newly intubated critically ill patients. The secondary objective is to determine the effect of an early RM on cardiac function. We hypothesize an early RM to…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is regional lung aeration, assessed by EIT.
Secondary outcome
The secondary endpoint is RV*function measured by contractile *, preload * and
afterload*parameters, assessed by TTE.
Background summary
Mechanical ventilation using a so*called *open lung* approach has the potential
to improve oxygenation, and even to reduce ventilator*associated lung injury,
in intensive care unit (ICU)*patients. An *open lung approach* requires
recruitment maneuvers (RMs). It is uncertain when to apply RMs: early after
tracheal intubation in each patient, or on indication in patients in whom
oxygenation worsens. It is also uncertain whether RM compromises cardiac
function of ICU*patients.
Methods
Main study parameters/endpoints
Study objective
The primary objective of this study is to compare the effect of a standard and
early RM in newly intubated critically ill patients. The secondary objective is
to determine the effect of an early RM on cardiac function. We hypothesize an
early RM to have a sustained effect on lung aeration while improving cardiac
function.
Study design
This study is a single*center randomized controlled trial of critically ill
patients who need tracheal intubation for mechanical ventilation.
Study population
Intervention
Consecutive newly intubated critically ill patients are randomized to
ventilation using an early RM (i.e., within thirty minutes after intubation) or
ventilation not using an early RM (i.e., a RM is performed only when
oxygenation is severely compromised). Lung aeration is determined by electric
impedance tomography (EIT), cardiac function by trans*thoracic echocardiography
(TTE). EIT and TTE are performed directly after tracheal intubation, after 1
and 2 hours, and after 24 hours.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness
A RM is a safe procedure in experienced hands. In this study only trained and
experienced ICU*physicians perform the RMs. Patients who are randomized to
early RM could potentially benefit from this study. EIT and TTE are
non-invasive, standard procedures in our ICU, and performed when patients are
still sedated.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All patients who need intubation for mechanical ventilation in the intensive care department
Exclusion criteria
o Age < 18 years
o Presence of a pacemaker or automatic cardiac defibrillator
o Presence of any implantable pumps
o Presence of thoracal drains
o Skin abnormalities impairing attachment of electrodes
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 | NL43859.018.13 |