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High Resolution Manometry for Swallowing (HRM)

This study has been terminated.
(Study has been halted per PI and IRB recommendation)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01773330
First Posted: January 23, 2013
Last Update Posted: January 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
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.

Condition Intervention Phase
Motility Disorder Procedure: esophageal manometry Dietary Supplement: Gatorade Other: Supine position Other: Semi-recumbent position Procedure: Sitting Procedure: Standing Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: High Resolution Manometry: Optimizing the Swallow Protocol

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits. [ Time Frame: up to 1 hour ]
    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.


Secondary Outcome Measures:
  • Normal HRM values for a 200 ml provocative swallow. [ Time Frame: up to 5 minutes ]
    The patient is instructed to swallow 200 ml of Gatorade in the sitting position.

  • Bolus clearance for each swallow with impedance. [ Time Frame: up to 1 hour ]
    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.

  • Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance. [ Time Frame: up to 1 hour ]
    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.

  • Standardization of the testing protocol for HRM and the reliability of volume and number of swallows. [ Time Frame: up to 1 hour ]
    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.


Enrollment: 71
Study Start Date: October 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Sitting position
  • Standing up
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:
  • Supine
  • Semi-recumbent
  • 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
  • Semi-recumbent position
  • Sitting position

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773330


Locations
United States, Florida
Shands Endoscopy Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Qing Zhang, M.D., Ph.D. University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01773330     History of Changes
Other Study ID Numbers: 502-2012
First Submitted: January 11, 2013
First Posted: January 23, 2013
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by University of Florida:
high resolution manometry
provocative swallow
impedence