The primary objective for this study is to compare the level and time course of the patient work-of-breathing during PS ventilation with the work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per minute delivered by the…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The level and time course of the patient work-of-breathing measured by the area
under the pressure-volume curve during PS ventilation with the
work-of-breathing during SIMV-PS ventilation with a lower rate of breaths per
minute delivered by the ventilator.
Secondary outcome
The level and time course of surrgatoe parameters for work-of-breathing (PRP,
PTP, expiratory airway resistance, imposed work of breathing), distribution of
tidal volume, and level and time course of oxygenation (PaO2/FiO2 ratio) during
PS ventilation with the work-of-breathing during SIMV-PS ventilation with a
lower rate of breaths per minute delivered by the ventilator.
Background summary
The most common approach to weaning infants and children is gradual reduction
of ventilatory support. Weaning with intermittent mandatory ventilation (IMV)
or synchronized IMV (SIMV) occurs by reducing the ventilatory rate. With
pressure support (PS) ventilation, the inspiratory pressure is initially set to
provide the required support and then reduced gradually. PS is often combined
with IMV/SIMV during weaning (SIMV-PS). Alternatively, another approach to
weaning is attempted with alternating periods of complete ventilatory support
and graded spontaneous breathing with assistance. This *sprinting* is performed
on the theory that the respiratory muscles can be slowly trained to sustain
complete spontaneous breathing. Also, theoretically this *sprinting* allows a
better distribution of the tidal volume in the lung. Interestingly, both
approaches are used simultaneously: the decision to use either one or both
approaches is dependent upon the preferences of the attending physician as
described in many observational single center studies. Children ventilated in
the PICU of the Beatrix Children*s Hospital are weaned from the mechanical
ventilator using both the gradual weaning and the sprinting
approach.Importantly, there is no data comparing the *sprinting* approach with
more traditional approaches of weaning in children with respect to patient
work-of-breathing. Work-of-breathing is defined by the physiologic work a
patient has to deliver to expand the lungs and the chest wall. It can be
assessed by various means:
•Bedside: tachypnoea and the presence of nasal flaring and intercostal and/or
interjugular retractions indicate increased work of breathing
•Clinical surrogate parameters: the ratio of the inspiratory time to total
breathing cycle time, the oesophageal pressure - rate product (PRP),
oesophageal pressure - time product (PTP) and expiratory airway resistance
(i.e. the difference in transpulmonary pressure and compliance, divided by
flow). These clinical surrogate parameters require the presence of an
oeosphageal catheter to measure the pressure. These catheters are routinely
present in ventilated patients as they are used for nasogastric tube feeding;
modern catheters can also measure the oesophageal pressure (i.e. double
function).
•Mathematically: the area under the oesophageal pressure - volume curve. This
is the classic and traditional approach to measure work of breathing. Its
normal value is within the range of 0.5 - 1.0 J/L. The variable is measured by
a commercially available ventilator (AVEA, CareFusion, Yorba Linda, CA, USA).
To measure this parameter, an oesophageal catheter is necessary.
Study objective
The primary objective for this study is to compare the level and time course of
the patient work-of-breathing during PS ventilation with the work-of-breathing
during SIMV-PS ventilation with a lower rate of breaths per minute delivered by
the ventilator. The secondary objectives for this study are to compare the
level and time course of the PRP, PTP, imposed work of breathing and the
PaO2/FiO2 ratio as well as the distribution of tidal volume in the lung during
PS ventilation with the work-of-breathing during SIMV-PS ventilation with a
lower rate of breaths per minute delivered by the ventilator.
Study design
This is a prospective observational study without invasive measurements in a 20
bed tertiary paediatric intensive care facility at the Beatrix Children*s
Hospital/University Medical Centre Groningen. The study will start December 1,
2011 and is completed by November 30, 2012.
Study burden and risks
There are no specific benefits for the patients who participate in the study.
However, the risks associated with this study are minimal, based upon the
following arguments:
•Blood sample drawing is done via the already present indwelling arterial line,
so that no additional venous or arterial punctures are necessary (routine
clinical care)
•All patients already have a nasogastric tube inserted that is capable of
measuring the oesophageal pressure (routine clinical care)
•All parameters collected in this study are real-time displayed on either the
ventilator or the pulmonary function monitor; only the EIT analyses are
performed off-line. For the EIT measurements 16 electrodes must be placed
circumferentially around the chest. However, these electrodes are fully
comparable with the electrodes routinely used for ECG monitoring; hence they
pose no additional burden
•There are no invasive measurements for this study
•There is no interference with clinical management of the patients for this
study.
Hanzeplein 1
Groningen 9713 HZ
NL
Hanzeplein 1
Groningen 9713 HZ
NL
Listed location countries
Age
Inclusion criteria
•mechanical ventilation for at least 48 hours before the start of weaning
•weight >= 3 kg
•deemed eligible for weaning by the attending physician
•stable haemodynamics, defined by the absence of need for increase in vaso-active drugs and/or fluid challenges at least 6 hours prior to enrolment
Exclusion criteria
•mechanical ventilation less than 48 hours for unplanned admissions before the start of weaning
•post-operative admission with expected duration of mechanical ventilaton less than 48 hours
•not eligible for weaning as assessed by the attending physician (usually when there are unstable ventilator settings, defined by the need for increase of inspiratory pressures or positive end-expiratory pressure, and a FiO2 > 0.6 within 6 hours prior to enrolment)
•unstable haemodynamics, defined by the need for increase in vaso-active drugs and/or fluid challenges within 6 hours prior to enrolment
•admitted to the neonatal intensive care unit
•premature birth with gestational age corrected for post-conceptional age less than 40 weeks
•congenital or acquired neuromuscular disorders
•congenital or acquired central nervous system disorders with depressed respiratory drive
•severe traumatic brain injury (i.e. Glasgow Coma Scale < 8)
•congenital or acquired damage to the phrenic nerve
•congenital or acquired paralysis of the diaphragm
•use of neuromuscular blockade prior to enrolment
•uncorrected congenital heart disorder
•chronic lung disease
•severe pulmonary hypertension
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 | NL38361.042.11 |