A Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux

NCT02457429 | Completed

• 1 other identifier: R01843
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a variety of symptoms in both adult and paediatric populations. In children the effects of refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory factor in the underlying pathological processes of a number of conditions including apnoea, asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The absence of typical symptoms in addition to the inability to obtain a formal symptom history from a young paediatric population contributes to the difficulty in establishing a diagnosis. At present there are no studies or data directly measuring extraoesophageal reflux and its correlation to oesophageal pH monitoring in children. The use of twenty-four hour oesophageal pH monitoring is regarded as the established technique for diagnosis of GORD, however this technique has been less reliable for detecting extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a sensitive and minimally invasive transnasal device, to assess the feasibility and validate its use in a paediatric population.

Conditions

Gastro-oesophageal Reflux

Keywords

Gastro-oesophageal reflux; Children; Dx-pH Pharyngeal probe; GORD; Trans-nasal catheter

Outcome Measures

Primary Outcomes (5)

• pH readings from Dx-pH measurement system

  Baseline pH readings from Dx-pH measurement system. Measuring reflux events at pH \<4, \<4.5, \<5.0 and \<6.0.

  24 hours

• pH readings from Dx-pH measurement system

  Baseline pH readings from Dx-pH measurement system. Measuring events per hour at pH \<4, \<4.5, \<5.0 and \<6.0

  24 hours

• pH readings from Dx-pH measurement system

  Baseline pH readings from Dx-pH measurement system. Measuring total reflux time at pH \<4, \<4.5, \<5.0 and \<6.0.

  24 hours

• pH readings from Dx-pH measurement system

  Baseline pH readings from Dx-pH measurement system. Measuring percentage reflux time at pH \<4, \<4.5, \<5.0 and \<6.0.

  24 hours

• pH readings from Dx-pH measurement system

  Baseline pH readings from Dx-pH measurement system. Measuring the longest reflux period at pH \<4, \<4.5, \<5.0 and \<6.0.

  24 hours

Secondary Outcomes (7)

• Conventional oesophageal pH / impedance readings

  24 hours

• Conventional oesophageal pH / impedance readings

  24 hours

• Conventional oesophageal pH / impedance readings

  24 hours

• Conventional oesophageal pH / impedance readings

  24 hours

• Conventional oesophageal pH / impedance readings

  24 hours

Study Arms (1)

Routine oesophageal pH monitoring

OTHER

Routine oesophageal pH investigation involves the trans-nasal placement of a microelectrode into the distal oesophagus as per hospital protocol. Examining the oropharynx and confirming visualisation of the red LED at the catheter tip in the correct position just below the soft palate will confirm its position in the oropharynx. The internal pH value of the oesophagus is then continuously measured and recorded onto a small ambulatory device. The 2 catheters are connected to the ambulatory recording devices and recording commences. The duration of the investigation is 24 hours.

Device: Experiemental diagnostic procedure: Dx-pH measurement system; Other: Peptest assay; Other: GORD symptom questionnaire

Interventions

Experiemental diagnostic procedure: Dx-pH measurement system DEVICE

The Dx-pH Measurement system (Dx-pH; Respiratory Technology Corp., San Diego, CA) is a sensitive and minimally invasive transnasal device for detection of aerosolized extra-oesophageal acid reflux in the posterior oropharynx. The sterile single use Dx-pH catheter will be passed trans-nasally into the same nostril as the same nostril as the other catheter. The internal pH value of the oesophagus is then continuously measured and recorded onto a small ambulatory device. The 2 catheters are connected to the ambulatory recording devices and recording commences. The duration of the investigation is 24 hours.

Routine oesophageal pH monitoring

Peptest assay OTHER

A saliva sample of 0.5-1 ml will then be taken for pepsin assay (Peptest). The saliva sample will be drawn into a micro-centrifuge tube (0.5ml) and centrifuged. 80 microlitres is taken from the supernatant layer, vortex mixed, then applied to the assay test strip. The result is obtained after 15 minutes. The saliva sample will then be securely disposed.

Routine oesophageal pH monitoring

GORD symptom questionnaire OTHER

A validated 7 domain GORD symptom questionnaire (GSQ-YC) to quantify the GORD related symptoms their child suffers with is to be completed prior to any intervention.

Also known as: (GSQ-YC)

Routine oesophageal pH monitoring

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children between the age of 1 year old and 16 years old consecutively referred for outpatient 24 hour oesophageal pH / impedance monitoring will be invited to participate in the study. This is regardless of the underlying diagnosis, aetiology and manifestation of symptoms.

You may not qualify if:

• Children under the age of 1 year old. Children under 1 year old will be excluded due to the technical difficulty of placing both the pH / impedance monitoring probe and the Dx-pH probe into the same nostril. Firstly, this is due to the size restriction of placing 2 probes into one nostril. Secondly, the non-pathologic high incidence of regurgitation and positing in below the age of 1 will make data difficult to interpret.
• Children with an nasogastric feeding tube in situ will be excluded. Firstly due to the difficulty in placing and securing the nasogastric, oesophageal pH and Dx-pH probe (3 tubes / probes) through the nostrils, with resultant bilateral nasal obstruction. Secondly, the nasogastric tube causes increased iatrogenic reflux within the pharynx, making data more difficult to interpret and creating artificial reflux events.
• Children with cleft palate prior to surgical repair will be excluded as the Dx-pH probe will be difficult to locate in the oropharynx and may displace into the oral cavity.
• Children requiring pH monitoring as inpatients during an acute medical admission. Children will be excluded from the study if their condition has necessitated an acute hospital admission, therefore participation in the study will not affect other ongoing investigations, treatment or their acute condition.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Iain A Bruce

  Royal Manchester Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: May 29, 2015
• Study Start: March 22, 2013
• Primary Completion: April 28, 2017
• Study Completion: April 28, 2017
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

GB (1)