High Resolution Manometry for Swallowing (HRM)

High Resolution Manometry: Optimizing the Swallow Protocol

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.

Study Overview

• Status: Terminated
• Conditions: Motility Disorder
• Intervention / Treatment: Procedure: esophageal manometry; Dietary supplement: Gatorade; Other: Supine position; Other: Semi-recumbent position; Procedure: Sitting; Procedure: Standing

Detailed Description

The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Shands Endoscopy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: esophageal manometry; 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; 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.; Dietary supplement: Gatorade; The patient will be given Gatorade to drink at various times during the study.; Other: Supine position; 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.; Other Names: Semi-recumbent; Sitting; Standing up; Other: Semi-recumbent position; 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.; Other Names: Supine position; Standing up; Sitting position; Procedure: Sitting; 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.; Other Names: Semi-recumbent; Supine; Standing; Procedure: Standing; 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.; Other Names: Supine position; Sitting position; Semi-recumbent position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal HRM values for a 200 ml provocative swallow.	The patient is instructed to swallow 200 ml of Gatorade in the sitting position.	up to 5 minutes
Bolus clearance for each swallow with impedance.	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
Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.	The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.	up to 1 hour
Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.	The patient is instructed to swallow different amounts of Gatorade. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up.	up to 1 hour

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Qing Zhang, M.D., Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 21, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: high resolution manometry; provocative swallow; impedence
• Other Study ID Numbers: 502-2012