Hypopharyngeal Mean PressureNCT05420428
Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery
A study testing supraglottic airway device and endotracheal intubation in people with Hypopharyngeal Mean Pressure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does by using high resolution impedance manometry. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hypopharyngeal Mean Pressure
- What is being tested?
- supraglottic airway device and endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jun 2022to 4 Dec 2023
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients receive orthopedic surgery with older than 60 years old including 60 years old.
Who cannot join
- The patients had severe major organ dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery: a Pilot Randomized Controlled Trial
We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does by using high resolution impedance manometry. We expected that the patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.
Read the detailed description
Background: More and more older patients required to receive orthopedic surgery recently. The intubation or supraglottic airway device are required to maintain airway during general anesthesia. Previous studies only reported the subjective swallowing discomfort feeling, however, the objective data was limited. The high-resolution impedance manometry could detect the swallowing muscle power changes with multiple pressure sensors and impedance channels.
Objectives: we aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does Patients and methods: The patients receive orthopedic surgery with older than 60 years old. They received high resolution impedance manometry examination at preoperative day, in the post-anesthetic care unit, postoperative day 3 to 7 (pick a day) along with subjective questionnaires. We also followed the IDDSI guideline to test different viscosity of the patients' tolerance for food.
Expected result: The patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.
- Conditions
- Hypopharyngeal Mean Pressure
- Being tested
- supraglottic airway device, endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraglottic airway deviceDevice
Also called laryngeal mask airway
under general anesthesia, patients received supraglottic airway device
endotracheal intubationDevice
under general anesthesia, patients received endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| endotracheal intubation | Placebo comparator | under general anesthesia, patients received tracheal intubation. Receives: Device: endotracheal intubation |
| supraglottic airway device | Experimental | under general anesthesia, patients received supraglottic airway device Receives: Device: supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypopharyngeal mean peak pressure
hypopharyngeal pressure during food bolus transmittion
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start21 Jun 2022
- Primary completion2 Nov 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal Mean PressureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controll group: tracheal intubation; intervention group: supraglottic airway device
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420428
- Sponsor's protocol ID
- 202204071RINC
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05420428
- Acronym / sponsor ID
- 202204071RINC
- Conditions
- Hypopharyngeal Mean Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 15 Jun 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.
We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does by using high resolution impedance manometry. We expected that the patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.
Detailed description
Background: More and more older patients required to receive orthopedic surgery recently. The intubation or supraglottic airway device are required to maintain airway during general anesthesia. Previous studies only reported the subjective swallowing discomfort feeling, however, the objective data was limited. The high-resolution impedance manometry could detect the swallowing muscle power changes with multiple pressure sensors and impedance channels.
Objectives: we aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does Patients and methods: The patients receive orthopedic surgery with older than 60 years old. They received high resolution impedance manometry examination at preoperative day, in the post-anesthetic care unit, postoperative day 3 to 7 (pick a day) along with subjective questionnaires. We also followed the IDDSI guideline to test different viscosity of the patients' tolerance for food.
Expected result: The patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- controll group: tracheal intubation; intervention group: supraglottic airway device
| Arm | Type | Receives |
|---|---|---|
| endotracheal intubation | Placebo comparator | Device: endotracheal intubationunder general anesthesia, patients received tracheal intubation. |
| supraglottic airway device | Experimental | Device: supraglottic airway deviceunder general anesthesia, patients received supraglottic airway device |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients receive orthopedic surgery with older than 60 years old including 60 years old.
Key exclusion criteria (1 listed)
- The patients had severe major organ dysfunction
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 |
|---|---|---|
| supraglottic airway deviceAlso: laryngeal mask airwayunder general anesthesia, patients received supraglottic airway device | Device | supraglottic airway device |
| endotracheal intubationunder general anesthesia, patients received endotracheal intubation | Device | endotracheal intubation |
Primary outcome
hypopharyngeal mean peak pressure
Time frame: 15 minutes
hypopharyngeal pressure during food bolus transmittion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No. ethical issue
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supraglottic airway device and endotracheal intubation in people with Hypopharyngeal Mean Pressure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Feb 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hypopharyngeal mean peak pressure (time frame: 15 minutes). 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 7 Feb 2024.