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Using gentle sinus drainage to stop food or liquid going into the lungs in ICU patients with swallowing problems

Continuous low-pressure pyriform sinus drainage to prevent silent aspiration in ICU-acquired dysphagia: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32097116
Enrollment
239
Registered
2025-12-23
Start date
2024-02-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Continuous low-pressure pyriform recess drainage to prevent occult aspiration in ICU-acquired dysphagia patients Infections and Infestations

Interventions

Eligible ICU patients (adults) were screened after =48 hours of invasive mechanical ventilation and following extubation/decannulation. Dysphagia was confirmed within 24 hours using the Gugging Swallo
positioning/postural adjustments
swallowing rehabilitation exercises
airway secretion management and suctioning when needed
cautious feeding/texture modification and feeding intolerance management
and oral care. Intervention group (standard care + pyriform sinus suction drainage): In addition to the same standard care bundle, participants received continuous low-pressure suction drainage of on
correct placement was confirmed endoscopically. The catheter was secured, connected to continuous low vacuum suction, and checked each nursing shift for position/patency. Suction was discontinued when

Sponsors

Fujian Provincial Hospital
Lead Sponsor
Fujian Medical University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. ICU admission with invasive mechanical ventilation for = 48 hours and extubation 3. Conscious patients assessed as having ICU-ASD by GUSS within 24 hours of extubation 4. Tracheostomy patients who have recovered stable consciousness and are able to complete functional assessments 5. Agree to participate in this study and sign informed consent form

Exclusion criteria

Exclusion criteria: 1. Impaired consciousness preventing completion of swallowing assessment 2. Severe cognitive impairment or mental illness 3. Comorbid severe oropharyngeal bleeding tendency or coagulation dysfunction 4. Pre-existing aspiration or aspiration pneumonia 5. Comorbid gastroesophageal reflux or tracheoesophageal fistula, or other diseases that may affect the study results

Design outcomes

Primary

MeasureTime frame
Swallowing function recovery time measured using data collected from medical records on the number of days from randomization to the first day the patient achieved full oral intake of regular solids and thin liquids without signs of aspiration, maintained SaO2 >90% on room air during swallowing, and had a normal swallow exam by the speech therapist (Gugging Swallowing Screen [GUSS] score = 20) at a daily assessment by ICU nurses and formal evaluation every 2–3 days by a trained speech-language pathologist until recovery or censored (ICU discharge or day 28);ICU length of stay (LOS) measured using data collected from medical records on the number of days from ICU admission to ICU discharge (or death in ICU if applicable) at one time point

Secondary

MeasureTime frame
Incidence of silent aspiration, in the absence of overt clinical signs of aspiration (no coughing, choking, wet voice, or desaturation during the event) measured using the detection of pepsin (>25 ng/mL by quantitative ELISA, PepTest®) in tracheal aspirates (intubated patients) or oropharyngeal/tracheal secretions (extubated or tracheostomized patients) at study days 1, 3, 5, and 7;Incidence of aspiration pneumonia measured using data collected from medical records on new lung infiltrate on chest X-ray plus =2 of the following: fever >38°C or WBC >12×10?/L, purulent sputum, positive respiratory culture; and evidence of aspiration risk (witnessed aspiration event or positive pepsin assay in respiratory secretions); all cases were adjudicated by two independent ICU physicians blinded to allocation at one time point;28-day and 90-day all-cause mortality measured using data collected from medical records on all-cause mortality recorded at day 28 and day 90 after ICU admission, confirmed via hospital records and post-discharge telephone follow-up at at one time point;Inflammatory markers: Serum C-reactive protein (CRP, mg/L) and white blood cell count (WBC, ×10?/L) measured using standard hospital laboratory methods (routine venous blood sampling; CRP assay performed in the central laboratory; automated hematology analyser) at ICU day 5 (±1 day) (with baseline values recorded at enrolment/ICU admission as per routine clinical practice);Swallowing-related outcomes measured using the Gugging Swallowing Screen (GUSS) score (0–20) at daily until recovery time to resumption of any oral feeding (days from randomization to first successful oral intake of any consistency), or need for re-intubation for airway protection

Countries

China

Contacts

Public ContactLi;Li Yun;Yun

;

xyunyun1987@gmail.com;532019705@qq.com+86 15960166892;+86 15960166892

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026