High Resolution Manometry for Swallowing

NCT01773330 | Terminated Phase 1

• 1 other identifier: 502-2012
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.

Conditions

Motility Disorder

Keywords

high resolution manometry; provocative swallow; impedence

Outcome Measures

Primary Outcomes (1)

• Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.

  The patient is instructed to swallow a determined volume of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.

  up to 1 hour

Secondary Outcomes (4)

• Normal HRM values for a 200 ml provocative swallow.

  up to 5 minutes

• Bolus clearance for each swallow with impedance.

  up to 1 hour

• Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.

  up to 1 hour

• Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.

  up to 1 hour

Study Arms (1)

esophageal manometry

EXPERIMENTAL

Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.

Procedure: esophageal manometry; Dietary Supplement: Gatorade; Other: Supine position; Other: Semi-recumbent position; Procedure: Sitting; Procedure: Standing

Interventions

esophageal manometry PROCEDURE

Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed.There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.

esophageal manometry

Gatorade DIETARY_SUPPLEMENT

The patient will be given Gatorade to drink at various times during the study.

esophageal manometry

Supine position OTHER

Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.

Also known as: Semi-recumbent, Sitting, Standing up

esophageal manometry

Semi-recumbent position OTHER

Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.

Also known as: Supine position, Sitting position, Standing up

esophageal manometry

Sitting PROCEDURE

Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.

Also known as: Supine, Semi-recumbent, Standing

esophageal manometry

Standing PROCEDURE

Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.

Also known as: Supine position, Semi-recumbent position, Sitting position

esophageal manometry

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Healthy Volunteer
• No clinical evidence of dysphagia

You may not qualify if:

• History of prior dysphagia
• Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
• Known gastrointestinal malignancy
• Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
• Previous esophageal or gastric surgery
• Significant cardiac or respiratory disease
• Pregnancy (a pregnancy test will be performed in women of child-bearing potential)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands Endoscopy Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Interventions

gatorade; Supine Position; Sitting Position; Standing Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Qing Zhang, M.D., Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 23, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

US (1)