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Esophageal Manometry During Recovery From Anesthesia: Pilot Study (EMAP)

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ClinicalTrials.gov Identifier: NCT02661386
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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 general anesthesia, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
  3. 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.
  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.

Condition or disease Intervention/treatment Phase
Motility Function Device: Motility Procedure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Esophageal Manometry During Recovery From Anesthesia: Pilot Study
Actual Study Start Date : January 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Manometry Device
During the last 10 minutes of subjects "waking up" from anesthesia, the motility procedure will be performed.
Device: Motility Procedure
The use of esophageal manometry device during general anesthesia




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02661386


Contacts
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Contact: John P Cello, MD 415-206-4746 john.cello@ucsf.edu
Contact: Alex Rodas, CCRC 415-206-4746 alex.rodas@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Alex Rodas, CCRC    415-206-4746    alex.rodas@ucsf.edu   
Principal Investigator: John P Cello, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Stanley Rogers, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02661386    
Other Study ID Numbers: 14-15466
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No