Esophageal Manometry During Recovery From Endotracheal Intubation
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT05574465
- Status
- Not Yet Recruiting
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Conditions
- Motility Function
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- High resolution solid state manometry — DEVICEThe use of esophageal manometry device during removal of endotracheal tube by anesthesia
Study Details
1. An intact pharyngoesophageal reflex is essential to protect the upper airway from aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is essential at protecting the airway in all patients. 2. In patients, while under medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present. 3. With the cessation of anesthetics, accompanied by the reversal of nerve block, normal pharyngoesophageal peristaltic activity correlates with awakening the patient from anesthesia. This would be identified by the performance of esophageal manometry. 4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This verbally stimulated swallowing sequence correlated precisely with the return of objective pharyngoesophageal function.
Key Dates
- Start date
- Jul 1, 2025
- Status verified
- Oct 2022
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Other: Manometry DeviceAt 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms.
Primary Outcome Measure
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM): [ Time Frame: The change in Basal Pressures will be recorded at the end of procedure. ]
Central Contacts
- John P Cello, MD628-206-4767
- Alex Rodas, MA628-206-4746
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | John P Cello, MD (PRINCIPAL_INVESTIGATOR) Stanley J Rogers, MD (PRINCIPAL_INVESTIGATOR) |