The primary objective of this study is to evaluate whether use of the TrachFlush reduces the need for tracheal suctioning. In a selection of patients, one secondary objective is to ascertain the exact volume of airway secretions that is pushed past…
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 proportion of successful TrachFlush activations from start of the study to
complete weaning from the ventilator, or a maximum of 7 days (primary).
Secondary outcome
Secondary endpoints include the total number of TrachFlush activations during
the same time window (all patients), and the exact amount of airway secretions
pushed past and above the cuff of the endotracheal tube (in patients with a
tube allows subglottal suctioning).
Background summary
In intubated and mechanically ventilated critically ill patients, removal of
airway secretions is typically performed by tracheal suctioning, an
intervention that is labor*intensive and very unpleasant for the patient. The
current study tests the hypothesis that a novel secretion removal technology
named TrachFlush, that pushes airway secretions past and above the cuff of the
endotracheal tube, reduces the need for tracheal suctioning.
Study objective
The primary objective of this study is to evaluate whether use of the
TrachFlush reduces the need for tracheal suctioning. In a selection of
patients, one secondary objective is to ascertain the exact volume of airway
secretions that is pushed past and above the cuff of the endotracheal tube.
Study design
Open prospective intervention study.
Intervention
The attending nurses activate the TrachFlush when there are secretions present
in the larger airways that need to be removed. If this results into a push of
airway secretions past and above the cuff of the endotracheal tube, no further
action is needed. If unsuccessful, the nurse will perform a standard tracheal
suctioning procedure to remove the secretions. In a subset of patients with an
endotracheal tube that allows subglottal suctioning, the exact amount of airway
secretions present above the cuff will be measured each time the TrachFlush is
used.
Study burden and risks
Inappropriate deflation or inflation of the endotracheal cuff by the TrachFlush
could cause harm. However, the cuff pressure will be checked regularly, and if
necessary corrected, at least every time the TrachFlush has been used. Patients
may benefit from the intervention, as the need for tracheal suctioning may
reduce.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
admission to one of the participating ICUs;
intubated with an endotracheal tube containing a cuff;
receiving invasive mechanical ventilation; and
expected to need invasive ventilation beyond the following calendar day at the
moment of inclusion.
Exclusion criteria
age < 18 years;
known or suspected tracheal damage, e.g., after inhalation trauma, thorax
trauma, or intubation trauma;
any condition for which deflation of the endotracheal cuff is deemed
detrimental, e.g., in case high airway pressures are needed; and
any infection, or colonization with pathogens that require strict isolation of
the patient.
Design
Recruitment
Medical products/devices used
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 | NL75593.018.20 |