Esophageal Manometry During Recovery From Endotracheal Intubation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Motility Function
• Intervention / Treatment: Device: High resolution solid state manometry

Detailed Description

The emergence from routine general deep anesthesia with an endotracheal tube is a potentially dangerous time for patients. Patients cannot reliably maintain competence of the upper esophageal sphincter, thus aspiration of the contents from the mouth or regurgitated material from the stomach can be aspirated into the lungs leading to serious complications. In normal awake individuals the upper esophageal sphincter (also known as the cricopharyngeus or the inferior pharyngeal constrictor) is contracted and relaxes precisely timed with voluntary or involuntary swallowing. The swallowing sequence in normal awake persons begins with 1) the contraction of the upper and middle pharyngeal constrictors, 2) the posterior movement of the tongue and 3) the prompt relaxation of the contracted upper esophageal sphincter. Peristalsis then begins in the body of the esophagus leading contents to the stomach. The above is the normal sequence in humans, a process which maintains absolute separation of the airway and digestive passageways despite being in intimate proximity. During the early period of emergence from anesthesia, the aspiration risk is highest due to the sluggish return of the resting pressure in the upper esophagus and the lack of normal coordination with involuntary swallowing. Thus patients can't protect their airway by maintaining competence and appropriate relaxation of the upper esophageal sphincter. Routine high resolution solid state manometry is a standard routine technique is currently performed in awake patients sitting upright voluntarily requested to swallow small boluses of liquid. The entire sequence of events is studied using high resolution solid state manometry.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John P Cello, MD; Phone Number: 628-206-4767; Email: john.cello@ucsf.edu
• Study Contact Backup: Name: Alex Rodas, MA; Phone Number: 628-206-4746; Email: alex.rodas@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Principal Investigator: John P Cello, MD
      • Contact: Alex Rodas, MA; Phone Number: 628-206-4746; Email: alex.rodas@ucsf.edu
      • Principal Investigator: Stanley J Rogers, MD

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Manometry Device; At 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms.	Device: High resolution solid state manometry; The use of esophageal manometry device during removal of endotracheal tube by anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM):	High-resolution manometry (HRM) determination of return of cricopharyngeal function - Basal Pressures: Upper esophageal sphincter (mmHg) - normal (34-104)	The change in Basal Pressures will be recorded at the end of procedure.
The Residual Pressures of patients during High-Resolution Motility/Manometry (HRM):	- Residual Pressures: Upper esophageal sphincter (mmHg) - normal (<12.0)	The change in Residual Pressures will be recorded at the end of procedure.
The Wave Duration of patients during High-Resolution Motility/Manometry (HRM):	- Motility: Wave Duration (seconds) - normal (2.7-5.4)	The change in Wave Duration will be recorded at the end of procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients agreeing to study versus refusing study.	Percentage/number of patients/next of kin accepting protocol	During enrollment
Number of patients completing study.	Percentage/number of patients completing esophageal motility/manometry study.	At the completion of procedure
Duration of HRM	Duration (minutes) of motility/manometry research study during withdrawal of endotracheal intubation.	The HRM study of the cricopharyngeus will be measured for the 5 minute time period just before planned endotracheal extubation to the time during extubation and for the 5 minute period just after endotracheal extubation.

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2025
• Primary Completion (Anticipated): June 30, 2027
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Extubation; Manometry
• Other Study ID Numbers: 22-36634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No