Esophageal Manometry During Recovery From Endotracheal Intubation

Motility Function Clinical Trial

Official title:

Esophageal Manometry During Recovery From Endotracheal Intubation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05574465
• Other study ID #: 22-36634
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2025
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2022
• Source: University of California, San Francisco
• Contact: John P Cello, MD
• Phone: 628-206-4767
• Email: john.cello[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Motility Function

Intervention

Device:
• High resolution solid state manometry
The use of esophageal manometry device during removal of endotracheal tube by anesthesia

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Percentage of patients agreeing to study versus refusing study.	Percentage/number of patients/next of kin accepting protocol	During enrollment
Secondary	Number of patients completing study.	Percentage/number of patients completing esophageal motility/manometry study.	At the completion of procedure
Secondary	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.