Impact of continuous 'above cuff ventilation' on aspiration status in neurogenic dysphagia

Impact of continuous 'above cuff ventilation' on aspiration status in neurogenic dysphagia - VENTURA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033639

Enrollment

Registered

2024-06-21

Start date

2024-07-08

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R13.1

Interventions

Group 1: Patients in the verum group receive daily 'above cuff ventilation' (ACV) for 8 hours with a continuous flow rate of 2 L/min of medical compressed air. In addition, standard therapy consisting

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients with dysphagia and an inserted tracheostomy tube, -Tracheostoma (surgical or dilative) with partially unblocked tracheostomy tube (min. 6 hours per day), -Tracheal cannula with subglottic suction (Trachoe vario extract). The cannula must be approved for subglottic insufflation of compressed air (Trachoe vario extract: REF: 470, REF: 471 with CE approval), - Feasibility of the FEES -Written declaration of consent from the patient or their legal representative -There are no contraindications for the use of Trachoe tracheostomy tubes with subglottic suction line

Exclusion criteria

Exclusion criteria: -Participation in other interventional examinations, -tracheomalacia, -Patients with fresh tracheostomy (less than 7 days after stoma creation) -ENT tumor surgery or radiation in the throat area, -Pre-existing oesophageal dysphagia (achalasia, motility disorder), -Continuous ventilation, -Obstruction of the upper airways -Patients with surgically induced emphysema or infections of the tracheal tissue -Pregnancy or breastfeeding, -Persons who are in a dependent / employment relationship with the sponsor, supporter or investigator -Placement in an institution due to a court or official order. -Deep sedation

Design outcomes

Primary

Measure	Time frame
Primary parameters during FEES (pre-interventional/post-interventional): Secretion status (NZSS), swallowing safety (PAS), swallowing efficiency (Yale Residue Scale), pharyngeal sensitivity (touch technique)	—

Secondary

Measure	Time frame
Nutritional status (FOIS-G), decannulation rate	—

Countries

Germany

Contacts

Public ContactMathias Lehmann

Helios Klinikum Krefeld GmbH

mathias.lehmann@helios-gesundheit.de+49 2151 32 2696

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026