Primary objective:What is the incidence of an unsafe swallow situation (PAS score >= 6) after decannulation in ICU patients who had a safe swallow situation with a tracheal cannula prior to decannulation (PAS score < 6)?Secondary objective:-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dysfagie tijdens Intensive Care opname
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
How many patients during FEES 2 had a PAS score >= 6, who during FEES 1 had a
PAS score of 6 or
Secondary outcome
- Change in PAS score between FEES 1 ( with trachea cannula in) and FEES 2?
(after decannulation)
- Trachea cannula reinsertion after FEES 2.
- Dietary prescription based on IDSSI after FEES 1 and dietary prescription
based on IDDSI after FEES 2.
Background summary
During an Intensive Care admission, a large proportion of patients receive
invasive ventilation via an endotracheal tube. If severe muscle weakness has
developed during treatment, resulting in a long withdrawal period, a tracheal
cannula is often chosen for patient comfort. The IC-MCL aims to assess <24h
after percutaneous tracheal cannula placement whether speaking during
ventilation is possible.
As soon as a patient speaks during ventilation, the speech therapist is
consulted. At the time the cuff is emptied, the patient is able to undergo
swallow training because laryngeal lift is then better compared with a full
cuff. (Ding R et al., 2005)
Dysphagia in ICU patients with tracheotomy is common: 3% - 62%. (Zuercher P et
al., 2019) Our own research also shows that on the 1st day of practice, 93% of
ICU patients with a tracheotomy have an NPO diet using the International
Dysphagia Diet Standardisation Initiative (IDDSI) (Cichero JA et al., 2017). A
Flexible Endoscopic Evaluation of Swallowing (FEES) is the gold standard to
objectify swallowing function. (Jaghbeer M et al., 2023) During a FEES, the
following observation points are included: velo-pharyngeal closure, tongue base
activity, pharyngeal contraction, sensibility, salivation and laryngeal
function. These points lead to a Penetration Aspiration Score (PAS) (Rosenbek
et al,. 1996)
In the current protocol, the tracheal cannula is removed when the patient is no
longer dependent on ventilation. Positive pressure under the vocal cords is
important for safe swallowing function ( Brendan McGrath et al., 2016)
During withdrawal from ventilation and swallow training with empty cuff,
pressure under the vocal cords is maintained by positive end-expiratory
pressure (PEEP) from the ventilator. Because of this positive pressure,
sensibility in the oral pharynx is better than without pressure. (Skoretz S et
al., 2020) From my own observations, it is suspected that swallowing function
is reduced after decanulation, leading to a risk of aspiration and penetration
of food. However, this has not been studied in a structured manner. To
objectify safe swallowing during a FEES, the PAS score is used. (6)
1. Ding R, Logemann JA. Swallow physiology in patients with trach cuff inflated
or deflated: a retrospective study. Head Neck. 2005 Sep;27(9):809-13. doi:
10.1002/hed.20248. PMID: 16086414.
2. Zuercher P, Moret CS, Dziewas R, Schefold JC. Dysphagia in the intensive
care unit: epidemiology, mechanisms, and clinical management. Crit Care. 2019
Mar 28;23(1):103. doi: 10.1186/s13054-019-2400-2. PMID: 30922363; PMCID:
PMC6438038.
3. Jaghbeer M, Sutt AL, Bergström L. Dysphagia Management and Cervical
Auscultation: Reliability and Validity Against FEES. Dysphagia. 2023
Feb;38(1):305-8
4. Brendan McGrath et al. ACV: a novel technique for communication in the
ventilator-dependent tracheostomy patient. Journal Intensive Care Society. 2016
Feb;17(1):19-26. Doi: 10.1177/1751143715607549.
5. Skoretz S, Anger N, Wellman L, et al. A systematic review of tracheostomy
modifications and swallowing in adults. Dysphagia 2020;35:935-47.
6 Rosebek et al, a penetration aspiration scale. Dysphagia. 2016 March (11)
93-98.
Study objective
Primary objective:
What is the incidence of an unsafe swallow situation (PAS score >= 6) after
decannulation in ICU patients who had a safe swallow situation with a tracheal
cannula prior to decannulation (PAS score < 6)?
Secondary objective:
- Is there a change in swallowing function measured by the PAS-score during a
FEES before and after decannulation?
- What is the rate of FEES-indicated reinsertion of the tracheal cannula?
- What is the FEES-indicated change in dietary prescription after
decannulation.
Study design
Observational study.
Study burden and risks
- Coughing due to choking during FEES.
- Second FEES as aditional burden for the patient.
Hendri Dunantweg 2
Leeuwarden 8934 AD
NL
Hendri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
Adult patients admitted to the ICU who have a trachea cannula due to prolonged
withdrawal of ventilation and receive swallowing training from the speech
therapist
Exclusion criteria
- contra indication deflation cuff .i.e. trachea obstruction
- Patients diagnosed with ALS or other progressive neuromuscular disease
- Not proficient in speaking and/or understanding Dutch.
- delirium
- patients with a tracheostomy (for example patients after total laryngeal
extirpation)
- patients with oral feeding restrictions due to underlying medical conditions.
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 | NL88431.099.24 |