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High Resolution Manometry for Swallowing

High Resolution Manometry: Optimizing the Swallow Protocol

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01773330
Acronym
HRM
Enrollment
71
Registered
2013-01-23
Start date
2013-10-31
Completion date
2015-01-31
Last updated
2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motility Disorder

Keywords

high resolution manometry, provocative swallow, impedence

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.

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.

Interventions

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_SUPPLEMENTGatorade

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

OTHERSupine 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.

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.

PROCEDURESitting

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.

PROCEDUREStanding

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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.up to 1 hourThe 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

MeasureTime frameDescription
Normal HRM values for a 200 ml provocative swallow.up to 5 minutesThe patient is instructed to swallow 200 ml of Gatorade in the sitting position.
Bolus clearance for each swallow with impedance.up to 1 hourThe 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.up to 1 hourThe 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.up to 1 hourThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026