Determine the physiological effect of HFNO compared to COT in the extubation phase regarding respiratory effort and lung aeration.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is the difference in change in lung respiratory muscle effort
(mean ΔPES) at 24 hours post-extubation between the study groups.
Secondary outcome
Secondary parameters are differences in changes in respiratory effort at 2 and
4 hours post-extubation, difference in change in lung aeration (mean ΔEELI),
differences in tidal volume, Lung Ultrasound (LUS) score, dyspnea score, and
respiratory and sputum parameters between patients undergoing different
post-extubation oxygenation regimens.
Background summary
Despite the lack of clear clinical protocols, High Flow Nasal Oxygen (HFNO) is
used as post-extubation respiratory support. Although HFNO seems to reduce the
need for re-intubation, scepticism on its use persists as the mechanism of
action in post-extubation patients remains undefined. Monitoring weaning from
invasive mechanical ventilation while monitoring respiratory effort might help
to determine the added value of HFNO surrounding extubation. We hypothesize
that HFNO, compared to conventional oxygen therapy (COT), prevents
de-recruitment of the lung and reduces respiratory effort, and so provides a
physiologic clarification for the reduction in the need for reintubation.
Study objective
Determine the physiological effect of HFNO compared to COT in the extubation
phase regarding respiratory effort and lung aeration.
Study design
A physiologic, randomized clinical study comparing two standard of clinical
care therapies.
Intervention
Before extubation, patients are randomized to receive conventional oxygen
(reference group) or HFNO as oxygenation regimen after extubation.
Both groups will undergo several minimally invasive measurements surroundig
extubation, such as EIT, PES and Lung ultrasound score (LUS).
Study burden and risks
Respiratory effort will be monitored according to routine clinical protocols by
employing esophageal manometry, which is a minimally invasive and safe
procedure. During the post-extubation phase, patients will undergo several
additional non-invasive measurements. Risks associated with participation are
expected to be negligible as all measurements and all treatment regimens are
considered as standard of clinical care, and will now be applied as part of a
structured study protocol. Study results are expected to be relevant for all
patients weaning form IMV.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- Aged >= 18 years
- Receiving invasive mechanical ventilation >48 hours for any cause
- Scheduled for extubation as per local clinical guideline
- Provided informed consent
Exclusion criteria
- Any clinical situation preventing appropriate execution of study procedures,
such as;
o Severe agitated delirium
o Do not reintubate order
- The presence of a tracheostomy
- Respiratory acidosis, defined as a pH <7.32 with hypercapnia (PCO2 >6.5 kPa /
PCO2 > 50 mmHg) during or after SBT
- Any feature that prohibits HFNO-initiation
o Recent facial upper-airway surgery
o Anatomic abnormalities that preclude appropriate fitting of HFNO
cannula
o Current exacerbation of obstructive pulmonary disease
- Obstructive/central Sleep Apnoea Syndrome or Obesity Hypoventilation Syndrome
in medical history
- Contra-indication for nasogastric tube or inability to perform adequate PES
measurements, e.g.:
o Recent esophageal surgery
o Prior esophagectomy
o Known presence of esophageal varices
o Severe bleeding disorders
- Known diaphragm paralysis defined as elevated hemi-diaphragm on X-ray or
evidence of paralysis during ultrasound (i.e. paradoxal diaphragm movement
during sniffing)
- Known pregnancy or current breast-feeding
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 | NL80844.078.22 |