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Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance

ConditionsExtraesophageal RefluxLaryngopharyngeal RefluxDysphagiaChronic Cough
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital Ostrava

About this trial

The aim of this project is to perform a detailed evaluation of upper esophageal sphincter function and the swallowing mechanism in patients with swallowing disorders or suspected extraesophageal reflux using high-resolution manometry with impedance and 24-hour pH-impedance monitoring.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-75 years

patients with swallowing difficulties suspected of having a functional oesophageal disorder or patients with clinical signs of extra-oesophageal reflux (Reflux Symptom Index [RSI] ≥ 13 or Reflux Symptom Score-12 [RSS-12] ≥ 11) signed informed consent

Disqualifiers

patients with a diagnosed tumor of the esophagus or upper airway, or with strong clinical suspicion of a tumor of the esophagus or upper airway

severe neurological disease affecting swallowing

pregnancy

surgery involving the head, neck, or esophagus within the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • High resolution oesophageal manometry with impedance

    Diagnostic test

    Patients with extraoesophageal reflux and dysphagia will undergo high resolution oesophageal manometry with impedance.

  • 24-hour pH metry

    Diagnostic test

    Patients with extraoesophageal reflux will undergo 24-hour pH-metry.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Extraoesophageal refluxExperimental treatment 2 interventions
Group B: DysphagiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PAET (Proximal Acid Exposure Time)

PAET (Proximal Acid Exposure Time) - acid exposure to the proximal oesophageus will be measured in per cent of the whole 24-h period.

Time frame
24 hours
2

Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP)

UES IRP is a measure of the extent of UES relaxation measured in mmHg

Time frame
15 minutes
3

UES Maximum Admittance

UES MaxAd is the highest admittance value recorded during trans-sphincteric bolus flow measured in milliseconds.

Time frame
15 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: