Esophageal Manometry During Recovery From Endotracheal Intubation (NCT05574465) | Clinical Trial Compass
WithdrawnNot Applicable
Esophageal Manometry During Recovery From Endotracheal Intubation
Stopped: Study never started.
United States0Started 2025-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients between 18 and 70 years of age (ASA I or II).
* Already scheduled for endotracheal tube extubation.
* Willing and able to give informed consent in either English or Spanish.
Exclusion Criteria:
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Patients not meeting entry criteria above.
* Refusal to give informed consent.
* Coagulopathy (INR \> 2 and/or platelet count \< 100,000.
* White Blood Cell count \< 5,000/mm3
* Arrhythmia
* Serum creatinine \> 2 mg/dl
* Prior known or suspected nasal obstruction.
* Known or suspected Zenker's diverticulum of esophagus, esophageal stricture, head/neck radiation therapy, hereditary telangiectasis, esophageal varices, cirrhosis.
* Anticoagulant usage such as heparin or Plavix
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM):
Timeframe: The change in Basal Pressures will be recorded at the end of procedure.
2
The Residual Pressures of patients during High-Resolution Motility/Manometry (HRM):
Timeframe: The change in Residual Pressures will be recorded at the end of procedure.
3
The Wave Duration of patients during High-Resolution Motility/Manometry (HRM):
Timeframe: The change in Wave Duration will be recorded at the end of procedure.