Motility FunctionNCT05574465
Esophageal Manometry During Recovery From Endotracheal Intubation
A study testing High resolution solid state manometry in people with Motility Function, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Motility Function
- What is being tested?
- High resolution solid state manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
- 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 medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
- 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.
- 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.
Read the 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.
- Conditions
- Motility Function
- Being tested
- High resolution solid state manometry
- Keywords
- Extubation, Manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution solid state manometryDevice
The use of esophageal manometry device during removal of endotracheal tube by anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Manometry Device | Other | At 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms. Receives: Device: High resolution solid state manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: The change in Wave Duration will be recorded at the end of procedure.
Secondary outcomes (3)
Percentage of patients agreeing to study versus refusing study.
Percentage/number of patients/next of kin accepting protocol
Measured: During enrollment
Number of patients completing study.
Percentage/number of patients completing esophageal motility/manometry study.
Measured: At the completion of procedure
Duration of HRM
Duration (minutes) of motility/manometry research study during withdrawal of endotracheal intubation.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility FunctionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects who meet the inclusion and exclusion criteria will be eligible for participation in this study. It is anticipated that the largest number of subjects will come from patients undergoing extubation in an intensive care unit (ICU).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley J Rogers, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574465
- Sponsor's protocol ID
- 22-36634
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2022
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Manometry During Recovery From Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT05574465
- Acronym / sponsor ID
- 22-36634
- Conditions
- Motility Function
- Keywords
- Extubation, Manometry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present.
- 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.
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects who meet the inclusion and exclusion criteria will be eligible for participation in this study. It is anticipated that the largest number of subjects will come from patients undergoing extubation in an intensive care unit (ICU).
| Arm | Type | Receives |
|---|---|---|
| Manometry Device | Other | Device: High resolution solid state manometryAt 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution solid state manometryThe use of esophageal manometry device during removal of endotracheal tube by anesthesia | Device | Manometry Device |
Primary outcome
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM):
Time frame: The change in Basal Pressures will be recorded at the end of procedure.
High-resolution manometry (HRM) determination of return of cricopharyngeal function - Basal Pressures: Upper esophageal sphincter (mmHg) - normal (34-104)
The Residual Pressures of patients during High-Resolution Motility/Manometry (HRM):
Time frame: The change in Residual Pressures will be recorded at the end of procedure.
- Residual Pressures: Upper esophageal sphincter (mmHg) - normal (<12.0)
The Wave Duration of patients during High-Resolution Motility/Manometry (HRM):
Time frame: The change in Wave Duration will be recorded at the end of procedure.
- Motility: Wave Duration (seconds) - normal (2.7-5.4)
3 secondary outcomes
Percentage of patients agreeing to study versus refusing study.
Time frame: During enrollment
Number of patients completing study.
Time frame: At the completion of procedure
Duration of HRM
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley J Rogers, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution solid state manometry in people with Motility Function, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Basal Pressures of patients during High-Resolution Motility/Manometry (HRM): (time frame: The change in Basal Pressures will be recorded at the end of procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.