To study the effects of varying amounts of air and patient position on oesophageal pressure measurements in children with and without lung injury.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peak-to-through oesophageal pressure at varying amounts of air in balloon
Secondary outcome
Peak-to-through oesophageal pressure at varying amounts of air in balloon and
body position (supine vs 30° upright
Background summary
Commercially available catheters (both for pediatric and adult use) are capable
of measuring esophageal pressure and display its value on commercially
available mechanical ventilators, and are even suitable for use in pre-term
born infants. However, the actual value of the esophageal pressure is amongst
others influenced by body position and the amount of air that is inflated into
the small balloon around the catheter. So far, these influences have not been
studied in mechanically ventilated children.
Study objective
To study the effects of varying amounts of air and patient position on
oesophageal pressure measurements in children with and without lung injury.
Study design
Non-therapeutic intervention study with invasive measurements
Intervention
Insertion esophageal cathether
Study burden and risks
The burden is negligible and the risks are minimal because the insertion of an
oesophageal catheter is to be considered an invasive procedure; however, the
procedure itself is comparable to inserting a nasogastric feeding tube that is
routinely done in all ventilated patients to ensure nasogastric tube feeding
and prevent gastric distension; the potential risk includes nasal bleeding,
misplacement (either to deep or not) or * very rarely * mucosal bleeding in the
oesophagus. To our best of knowledge, these complications have so far occurred
very rarely in our PICU. Misplacement into the trachea is very unlikely because
the endotracheal tube is already in place. Nonetheless, we will record any
complication that has occurred when inserting the oesophageal catheter.
Furthermore, correct position of the catheter is confirmed if the cardiac
signal is present in the pressure * time curve displayed by the ventilator. If
not, then the oesophageal catheter is removed. If this occurs, the oesophageal
catheter is re-inserted only once. The use of additional oesophageal catheters
to measure pressure in mechanically ventilated children has been approved by
local IRBs (NL26857.078.09; NL24044.029.08). Similar as for any procedure
clinically required, wewill measure the Comfort Score prior to insertion of the
oesophageal catheter; if necessary the dosage of sedation will be adjusted. The
nurse taking care of the patient will insert the catheter; he or she is fully
capable of inserting such a catheter. Finally, there is negligible risk of
sinusitis caused by obstruction of the ostium due to having temporarily two
catheters inserted because the occurrence of sinusitis in young mechanically
ventilated children is very uncommon and the study period is relatively short.
It is important to study the effects of PEEP in the paediatric context.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
* Informed consent
* Age younger than 12 years
* Need for mechanical ventilation with PEEP ><= 5 cmH2O
* Haemodynamically stable, assessed by the attending physician
Exclusion criteria
No informed consent
* Chronic respiratory failure on home ventilation
* Intracranial hypertension
* Bone marrow transplantation
* Immunocompromised patients (congenital or acquired)
* Pre-existing pulmonary hypertension
* Uncorrected congenital heart disease with left * to * right shunting or cyanotic heart disease
* Single ventricle laesions
* Evidence of esophageal pathology or the inability to pass a combined esophageal balloon/nasogastric feeding tube
* Contraindication to the passage of an esophageal pressure probe by either the oral or nasal route
* Withdrawal of life * sustaining treatment
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 | NL61872.000.17 |