Aspiration, RespiratoryNCT02604043
Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients
A study testing pH monitoring and accelerometer monitoring in people with Aspiration, Respiratory, run by Vanderbilt University at 1 site in United States.
Trial summary
This is a pilot prospective cohort study of the incidence of supraglottic pH readings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aspiration, Respiratory
- What is being tested?
- pH monitoring and accelerometer monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 1 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled to undergo robotic prostatectomy.
- Patients undergoing peritoneal tumor debulking and chemotherapy
- Mechanically ventilated Burn Intensive Care Unit (BICU) Patients
- Mechanically ventilated Neuro Care Unit (NCU) Patients who have suffered a stroke
Who cannot join
- ICU patients who are not receiving enteral feeds
- Patients who present for tumor debulking or robotic prostatectomy who receive preoperative H2 blockers, proton pump inhibitors, antacids or metoclopramide.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
This is a pilot prospective cohort study of the incidence of supraglottic pH readings.
Read the detailed description
Aspiration is a serious morbidity that leads to an increase in both patient mortality and duration of hospital stays. Many practices exist within the hospital setting whose goal is to help prevent clinically significant aspiration including preoperative starvation, pharmaceutically reducing gastric acidity, facilitating gastric drainage, postural changes, cricoid pressure, endotracheal cuff pressure modification, and maintenance of a competent lower esophageal sphincter. However, to date, no monitoring system exists to help a clinician identify active aspiration. At present, video fluoroscopy, is the gold standard for detecting aspiration. This pilot prospective cohort study will examine the incidence of supraglottic pH readings.
A continuous pH/impedence sensor will be placed immediately above the glottic opening in four high risk populations: burn patients who are intubated, intubated post-stroke patients, patients undergoing robotic prostectomy, and in patients undergoing peritoneal tumor debulking and chemotherapy. The presence of acidic fluid above the glottic opening will be measured using a supraglottic impendence/pH probe attached to an endotracheal tube.
- Conditions
- Aspiration, Respiratory
- Being tested
- pH monitoring, accelerometer monitoring
- Keywords
- supraglottic pH
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH monitoringOther
After endotracheal intubation, the impedence/pH probe will be placed under indirect visualization using a McGrath MAC video laryngoscope directly above the vocal cords. The sensor will remain in place for the duration of the surgery or for 24 hours in ICU patients. At that time, the device will be manually removed by a member of the study staff.
accelerometer monitoringOther
Patient position will be continuously monitored with the accelerometer for the duration of the pH monitoring period.
| Study group | Role | What they receive |
|---|---|---|
| supraglottic impendence/pH probe | Experimental | Not described Receives: Other: pH monitoring; Other: accelerometer monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times pH drops below 5.5.
Measured: 24 hours period after placement of pH probe
Secondary outcomes (1)
The mean of the angle (degrees) of the patient from the lateral position during low pH periods
Measured: 24 hours period after placement of pH probe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startAug 2016
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Lack of support to complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aspiration, RespiratoryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret Alvis, Vanderbilt University
- Investigators
- Brett Alvis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604043
- Sponsor's protocol ID
- 131893
- Status last verified
- Apr 2019
- First submitted
- 11 Nov 2015
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng A, Smith G. Gastroesophageal reflux and aspiration of gastric contents in anesthetic practice. Anesth Analg. 2001 Aug;93(2):494-513. doi: 10.1097/00000539-200108000-00050.
PubMed 11473886Clayton J, Jack CI, Ryall C, Tran J, Hilal E, Gosney M. Tracheal pH monitoring and aspiration in acute stroke. Age Ageing. 2006 Jan;35(1):47-53. doi: 10.1093/ageing/afj007.
PubMed 16364934
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients
- ClinicalTrials.gov ID
- NCT02604043
- Acronym / sponsor ID
- 131893
- Conditions
- Aspiration, Respiratory
- Keywords
- supraglottic pH
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of support to complete
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Nov 2015 (estimated)
- 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.
This is a pilot prospective cohort study of the incidence of supraglottic pH readings.
Detailed description
Aspiration is a serious morbidity that leads to an increase in both patient mortality and duration of hospital stays. Many practices exist within the hospital setting whose goal is to help prevent clinically significant aspiration including preoperative starvation, pharmaceutically reducing gastric acidity, facilitating gastric drainage, postural changes, cricoid pressure, endotracheal cuff pressure modification, and maintenance of a competent lower esophageal sphincter. However, to date, no monitoring system exists to help a clinician identify active aspiration. At present, video fluoroscopy, is the gold standard for detecting aspiration. This pilot prospective cohort study will examine the incidence of supraglottic pH readings.
A continuous pH/impedence sensor will be placed immediately above the glottic opening in four high risk populations: burn patients who are intubated, intubated post-stroke patients, patients undergoing robotic prostectomy, and in patients undergoing peritoneal tumor debulking and chemotherapy. The presence of acidic fluid above the glottic opening will be measured using a supraglottic impendence/pH probe attached to an endotracheal tube.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| supraglottic impendence/pH probe | Experimental | Other: pH monitoring, Other: accelerometer monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are scheduled to undergo robotic prostatectomy.
- Patients undergoing peritoneal tumor debulking and chemotherapy
- Mechanically ventilated Burn Intensive Care Unit (BICU) Patients
- Mechanically ventilated Neuro Care Unit (NCU) Patients who have suffered a stroke
Key exclusion criteria (2 listed)
- ICU patients who are not receiving enteral feeds
- Patients who present for tumor debulking or robotic prostatectomy who receive preoperative H2 blockers, proton pump inhibitors, antacids or metoclopramide.
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 |
|---|---|---|
| pH monitoringAfter endotracheal intubation, the impedence/pH probe will be placed under indirect visualization using a McGrath MAC video laryngoscope directly above the vocal cords. The sensor will remain in place for the duration of the surgery or for 24 hours in ICU patients. At that time, the device will be manually removed by a member of the study staff. | Other | supraglottic impendence/pH probe |
| accelerometer monitoringPatient position will be continuously monitored with the accelerometer for the duration of the pH monitoring period. | Other | supraglottic impendence/pH probe |
Primary outcome
Number of times pH drops below 5.5.
Time frame: 24 hours period after placement of pH probe
1 secondary outcome
The mean of the angle (degrees) of the patient from the lateral position during low pH periods
Time frame: 24 hours period after placement of pH probe
Results and safety
The study was stopped early (reason given: Lack of support to complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 11473886Ng A, Smith G. Gastroesophageal reflux and aspiration of gastric contents in anesthetic practice. Anesth Analg. 2001 Aug;93(2):494-513. doi: 10.1097/00000539-200108000-00050.
- Background: PubMed 16364934Clayton J, Jack CI, Ryall C, Tran J, Hilal E, Gosney M. Tracheal pH monitoring and aspiration in acute stroke. Age Ageing. 2006 Jan;35(1):47-53. doi: 10.1093/ageing/afj007.
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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.
Brett Alvis, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pH monitoring and accelerometer monitoring in people with Aspiration, Respiratory, run by Vanderbilt University 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Apr 2019. 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 stopped early (reason given: Lack of support to complete). Results are not available in the source record.
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?
Number of times pH drops below 5.5. (time frame: 24 hours period after placement of pH probe). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604043, which also lists 2 linked publications.
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 4 Apr 2019.