- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02661386
Esophageal Manometry During Recovery From Anesthesia: Pilot Study (EMAP)
February 10, 2021 updated by: University of California, San Francisco
- 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.
- In patients, while under general anesthesia, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
- With the cessation of general 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.
- 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.
Study Overview
Detailed Description
This pilot study will examine esophageal manometry in patients emerging from routine general anesthesia.
Manometry of the esophagus is not a standard part of surgery or general anesthesia.
The investigators will be using standard solid state high resolution manometry.
One of the authors (JPC) evaluates all routine manometry for patients undergoing such procedures at both UCSF and SFGH.
The use of manometry in patients recovering from anesthesia will permit the investigators to assess the recovery of a normal swallowing mechanism.
An adequate determination of return of normal swallowing sequence is likely to determine the safe time for extubation.
The investigators propose to, as a research study, investigate esophageal motor function using standard high resolution esophageal manometry in 10 patients recovering from general anesthesia.
These studies are likely to document that the return of normal pharyngoesophageal function will coordinate with verbal commands to initiate swallowing.
This pilot study will help clarify the precise timing of the return of normal function in the oropharynx and the proximal esophagus and thus determine the safe time for removal of the endotracheal or nasotracheal intubation.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: John P Cello, MD
- Phone Number: 415-206-4746
- Email: john.cello@ucsf.edu
Study Contact Backup
- Name: Alex Rodas, CCRC
- Phone Number: 415-206-4746
- Email: alex.rodas@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- Recruiting
- Zuckerberg San Francisco General Hospital
-
Contact:
- Alex Rodas, CCRC
- Phone Number: 415-206-4746
- Email: alex.rodas@ucsf.edu
-
Principal Investigator:
- John P Cello, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients between 18 and 70 years of age (ASA I or II).
- Already scheduled for routine general anesthetic procedure requiring an endotracheal tube for anesthesia administration.
- Scheduled abdominal surgical procedure including endoscopy, colonoscopy, ERCP, cholecystectomy, appendectomy, colectomy or small bowel resection.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Manometry Device
During the last 10 minutes of subjects "waking up" from anesthesia, the motility procedure will be performed.
|
The use of esophageal manometry device during general anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total time of the return of normal pharyngoesophageal function
Time Frame: During the last 15 minutes of general anesthesia use
|
Our primary objective is to determine the timing of the return of normal pharyngoesophageal function upon withdrawal of general anesthesia.
|
During the last 15 minutes of general anesthesia use
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with normal pharyngoesophageal function.
Time Frame: During the last 15 minutes of general anesthesia use
|
Correlation of the return of normal pharyngoesophageal function with other markers generally used by Anesthesia staff to indicate a safe time for removal of endotracheal tubes.
|
During the last 15 minutes of general anesthesia use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stanley Rogers, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
January 19, 2016
First Submitted That Met QC Criteria
January 20, 2016
First Posted (Estimate)
January 22, 2016
Study Record Updates
Last Update Posted (Actual)
February 11, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 14-15466
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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