Primary Objective: To determine the difference in change in sputum viscoelasticity on HME and HFTO during disconnection sessions from the ventilator in tracheotomised patients. Secondary Objective(s): 1. To determine the difference in respiratory…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end-point is the difference between HME and HFTO in change in
sputum viscoelasticity from baseline to the end of the long disconnection
sessions (>=12 hours). Viscoelastic (G*) is made up of elasticity (G*) and
viscosity (G**) of mucus at a 5% strain rate (or linear viscoelastic region,
which reflects the small deformation regime) and the critical stress (*
critical)· and strain (y critical) of mucus, which reflect the behavior of
mucus under high amounts of shear stress and thus the large deformation
regime.
Secondary outcome
1. The difference between HME and HFTO in change in sputum viscoelasticity from
baseline to the end (after 10-90 min) of the early disconnection session
2. The difference in respiratory effort between HME and HFTO during early
disconnection sessions measured by median PES-swing during the early
disconnection session.
3. The difference in frequency of presence of self-reported dyspnea sensation
and discomfort between HME and HFTO during early and late disconnection
sessions. Presence of self-reported dyspnea and discomfort is evaluated by
asking patients as described in section 8.3.
4. The difference in severity of self-reported dyspnea sensation and
experienced discomfort between HME and HFTO during early and late
disconnection. Severity of self-reported dyspnea and discomfort is evaluated
using a dyspnea visual-analog scale (D-VAS) as described in section 8.3.
Background summary
A majority of critically ill patients treated in the intensive care unit (ICU)
require invasive mechanical ventilation (iMV). Although iMV is an essential
part of treatment, its duration is directly linked to clinical outcomes.
Long-term iMV is expensive and requires a lot of intensive care resources. That
is why the early and safest possible release of iMV is one of the most
important goals and challenges in ICU care. Liberation is usually preceded by a
period of weaning off ventilation, which is often done with a tracheostomy in
patients with long-term iMV. Advantages of weaning with tracheostomy compared
to an endotracheal tube include a decreased need for sedatives, the ability to
eat and speak, and possibly a lower mortality rate.
Despite the significant burden on patients and ICU resources, insights into the
weaning phase with tracheostomy are limited. Patients with a tracheostomy are
at risk of dehydration of the airway mucosa and sputum accumulation during
weaning from mechanical ventilation. High-flow tracheal oxygen (HFTO) and
heat-moisture exchanger (HME) are used as adjunctive therapy during uncoupling
sessions in tracheostomy patients weaning from invasive mechanical ventilation
(IMV) to limit dryness while maintaining oxygenation. We recently summarized
the studies comparing the physiological effects of both interfaces in a
systematic review and identified areas where knowledge is lacking: the effect
on sputum viscoelasticity, respiratory effort early in the withdrawal process
and the sensation of shortness of breath . We hypothesize that HFTO, compared
to HME, reduces sputum viscoelasticity and provides respiratory support during
withdrawal. This may improve weaning by facilitating the clearance of mucus
from the airways, preventing respiratory failure, and providing comfort by
reducing shortness of breath.
Study objective
Primary Objective:
To determine the difference in change in sputum viscoelasticity on HME and HFTO
during disconnection sessions from the ventilator in tracheotomised patients.
Secondary Objective(s):
1. To determine the difference in respiratory effort between disconnection
sessions with HME and HFTO, as measured by swings in esophageal pressure (PES)
2. To determine the difference in presence and severity of self-reported
dyspnoea sensation and discomfort between disconnection sessions with HME and
HFTO.
Study design
Pilot physiological study with a randomized cross-over design
Intervention
Upon signing informed consent, patients will be randomized (1:1) in one of the
2 study arms, in order to eliminate any subjective clinical judgement whether a
patient is likely to benefit from HFTO and to control for confounding factors.
The study arms are start HME and cross over to HFTO, or start HFTO and cross
over to HME. The same order is used during measurements during disconnection
sessions early and late in the weaning phase. Randomization will be performed
through a web-based system (Castor) using computer-generated random numbers
with blocks of 2 and 4, unknown to the investigators. Blinding does not apply
as the intervention is not possible to blind.
Study burden and risks
The study compares two therapeutic modalities both used in clinical care
without side-effects or complications. Study procedures and measurements
consist of standard clinical procedures that are performed daily in clinical
setting with negligible risk of deterioration for the patient. During weaning
with HFTO sputum clearance might be more easy for the patient and respiratory
effort might decrease, both are assumed to be beneficial for the weaning
process of the patient.
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
• Age >=18 years
• Scheduled to wean from mechanical ventilation with tracheostomy
Exclusion criteria
• Longstanding tracheostomy, defined as tracheostomy being present prior to
current hospital admission
• Tracheostomy primarily indicated for chronic upper airway obstruction or to
secure airway patency due to persistent stupor/coma
• Chronic positive pressure respiratory support at home (excluding night-time
continuous positive airway pressure for sleep apnea)
• Mucociliary disease in medical history (e.g. cystic fibrosis, pulmonary
ciliary dyskinesia)
• Neuromuscular disease in medical history (excluding ICU-acquired weakness)
• Contra-indication placement oesophageal balloon for measurement of PES:
o Fractures in mandibular, orbital or ethmoid bone or skull base
o Esophageal varices or surgery in medical history
o Severe bleeding disorders
• Hemoptysis in 72 hours prior to the first disconnection session. Clinically
relevant hemoptysis is defined as hemoptysis requiring tracheal/endobronchial
or radiologic intervention, or administration of pro-coagulating drugs such as
tranexamic acid.
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 | NL87502.078.24 |