Post-extubation DysphagiaNCT06386159
Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism
A study testing Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation in people with Post-extubation Dysphagia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-extubation Dysphagia
- What is being tested?
- Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 30 Jul 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
- aged from 18 to 90 years old;
- oral or nasotracheal intubation for ≥48 hours;
- Clear mind
- Glasgow score ≥13 points, with good cooperation ability;
- There was no contraindication to oral feeding after extubation
Who cannot join
- Other diseases that affect swallowing function (such as stroke, Parkinson's disease, head and neck deformity, radiotherapy after head and neck cancer, burn with inhalation injury, esophageal cancer, chronic obstructive pulmonary disease, etc.);
- history of reflux and aspiration;
- tracheotomy;
- isolation treatment due to respiratory infectious diseases;
- the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
- Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jinhua Municipal Central Hospital
Jinhua
Haiping Xu, 13506587812, 240931013@qq.com
About this study
Official title: Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism
This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application.
- Conditions
- Post-extubation Dysphagia
- Being tested
- Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation
- Keywords
- post-extubation dysphagia, electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulationOther
Comprehensive intervention includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. Transcutaneous electrical stimulation of the vagus nerve at the lateral neck was performed by rehabilitation therapists. The cervical vagus nerve accompanies the carotid artery and is located at the groove between the trachea and the sternocleidomastoid muscle, which can be located by touching the carotid pulse. The two electrodes were pasted along the path of the cervical vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | During routine medical care and nursing, the responsible nurse provides daily oral care and delivers health education to patients and their caregivers regarding diet and swallowing safety. Within 8 hours after the removal of the endotracheal tube, the Standardized Swallowing Assessment (SSA) is used to screen for swallowing function. Patients are guided in food selection based on the severity of their swallowing difficulties and personal preferences, and are supplemented with enteral or parenteral nutrition or prescribed specific diets as directed by their doctor. |
| Comprehensive Intervention Group | Active comparator | On the basis of the control group, a comprehensive intervention plan determined through Delphi expert consultation is implemented for PED patients. This plan includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. The duration and frequency of the exercises are tailored to the patient's actual condition. Receives: Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation |
| Comprehensive Intervention Combined with Vagus Nerve Stimulation Group | Experimental | On the basis of the control group, a comprehensive intervention is implemented in combination with vagus nerve electrical stimulation. Receives: Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional oral intake scale（FOIS）
FOIS consists of seven levels: ① Score 1, unable to eat orally at all; ② Score 2, dependent on tube feeding, minimum attempt to eat food or liquid; ③ Score 3, dependent on tube feeding, taking single texture food or liquid orally; ④ Score 4, completely oral intake of single texture food; ⑤ score 5: fully oral intake of a variety of food textures, but with special preparation or compensation; ⑥6 points, completely oral feeding without special preparation, but with special food restriction; ⑦7 points, complete oral feeding without restriction, the higher the score, the better the swallowing function of the patient. In this study, a FOIS score of 6-7 was defined as full oral feeding
Measured: up to 90 days
standardized Swallowing Assessment（SSA）
The first part is the clinical examination.The second part involves observing the patient's ability to swallow 5 mL of water, repeated three times. If there are no abnormalities detected in the above examinations, the amount of water for swallowing is then increased to 60 mL. To obtain the total score, the scores from all three parts are summed up.
Measured: up to 90 days
Secondary outcomes (12)
Rate of total oral feeding after the intervention
After the intervention, the patient's score on the Functional Oral Intake Scale (FOIS) was between 6 and 7, indicating that the patient has recovered the ability to eat orally.
Measured: up to 90 days
Duration of Enteral Nutrition Tube Indwelling
The duration of the nasogastric tube or nasointestinal tube indwelling in the patient
Measured: up to 90 days
Rate of Re-intubation after Endotracheal Intubation
The rate of re-intubation during the intervention period after extubation in patients who have undergone endotracheal intubation
Measured: up to 90 days
Incidence of aspiration within one week after extubation
Incidence of aspiration within one week after extubation
Measured: up to 90 days
The incidence of aspiration pneumonia within one week after extubation
The incidence of aspiration pneumonia within one week after extubation
Measured: up to 90 days
Inflammation-related indicators: serum C-reactive protein (CRP)
Monitoring of patients' inflammatory marker
Measured: up to 90 days
Inflammation-related indicators: serum interleukin-6 (IL-6)
Monitoring of patients' inflammatory marker
Measured: up to 90 days
Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)
Monitoring of patients' inflammatory markers
Measured: up to 90 days
Inflammation-related indicators: high mobility group box-1 protein (HMGB1)
Monitoring of patients' inflammatory marker
Measured: up to 90 days
Days of ICU hospitalization
Days of ICU hospitalization
Measured: up to 90 days
Total days of hospitalization
Total days of hospitalization
Measured: up to 90 days
In-hospital survival rate
The number of patients who survive during hospitalization
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start15 Mar 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-extubation DysphagiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386159
- Sponsor's protocol ID
- 2023-1178
- Status last verified
- Mar 2024
- First submitted
- 24 Apr 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Comprehensive Intervention Scheme for Post-extubation Dysphagia Based on Neuroregulatory Mechanism
- ClinicalTrials.gov ID
- NCT06386159
- Acronym / sponsor ID
- 2023-1178
- Conditions
- Post-extubation Dysphagia
- Keywords
- post-extubation dysphagia, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Jinhua Municipal Central Hospital
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 26 Apr 2024 (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.
This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –During routine medical care and nursing, the responsible nurse provides daily oral care and delivers health education to patients and their caregivers regarding diet and swallowing safety. Within 8 hours after the removal of the endotracheal tube, the Standardized Swallowing Assessment (SSA) is used to screen for swallowing function. Patients are guided in food selection based on the severity of their swallowing difficulties and personal preferences, and are supplemented with enteral or parenteral nutrition or prescribed specific diets as directed by their doctor. |
| Comprehensive Intervention Group | Active comparator | Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulationOn the basis of the control group, a comprehensive intervention plan determined through Delphi expert consultation is implemented for PED patients. This plan includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. The duration and frequency of the exercises are tailored to the patient's actual condition. |
| Comprehensive Intervention Combined with Vagus Nerve Stimulation Group | Experimental | Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulationOn the basis of the control group, a comprehensive intervention is implemented in combination with vagus nerve electrical stimulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
- aged from 18 to 90 years old;
- oral or nasotracheal intubation for ≥48 hours;
- Clear mind
- Glasgow score ≥13 points, with good cooperation ability;
Key exclusion criteria (6 listed)
- Other diseases that affect swallowing function (such as stroke, Parkinson's disease, head and neck deformity, radiotherapy after head and neck cancer, burn with inhalation injury, esophageal cancer, chronic obstructive pulmonary disease, etc.);
- history of reflux and aspiration;
- tracheotomy;
- isolation treatment due to respiratory infectious diseases;
- the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
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 |
|---|---|---|
| Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulationComprehensive intervention includes multidisciplinary collaboration, screening and assessment, oral sensory training, oral motor training, respiratory training, and feeding management. Transcutaneous electrical stimulation of the vagus nerve at the lateral neck was performed by rehabilitation therapists. The cervical vagus nerve accompanies the carotid artery and is located at the groove between the trachea and the sternocleidomastoid muscle, which can be located by touching the carotid pulse. The two electrodes were pasted along the path of the cervical vagus nerve. | Other | Comprehensive Intervention Combined with Vagus Nerve Stimulation Group, Comprehensive Intervention Group |
Primary outcome
functional oral intake scale（FOIS）
Time frame: up to 90 days
FOIS consists of seven levels: ① Score 1, unable to eat orally at all; ② Score 2, dependent on tube feeding, minimum attempt to eat food or liquid; ③ Score 3, dependent on tube feeding, taking single texture food or liquid orally; ④ Score 4, completely oral intake of single texture food; ⑤ score 5: fully oral intake of a variety of food textures, but with special preparation or compensation; ⑥6 points, completely oral feeding without special preparation, but with special food restriction; ⑦7 points, complete oral feeding without restriction, the higher the score, the better the swallowing function of the patient. In this study, a FOIS score of 6-7 was defined as full oral feeding
standardized Swallowing Assessment（SSA）
Time frame: up to 90 days
The first part is the clinical examination.The second part involves observing the patient's ability to swallow 5 mL of water, repeated three times. If there are no abnormalities detected in the above examinations, the amount of water for swallowing is then increased to 60 mL. To obtain the total score, the scores from all three parts are summed up.
12 secondary outcomes
Rate of total oral feeding after the intervention
Time frame: up to 90 days
Duration of Enteral Nutrition Tube Indwelling
Time frame: up to 90 days
Rate of Re-intubation after Endotracheal Intubation
Time frame: up to 90 days
Incidence of aspiration within one week after extubation
Time frame: up to 90 days
The incidence of aspiration pneumonia within one week after extubation
Time frame: up to 90 days
Inflammation-related indicators: serum C-reactive protein (CRP)
Time frame: up to 90 days
Inflammation-related indicators: serum interleukin-6 (IL-6)
Time frame: up to 90 days
Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)
Time frame: up to 90 days
Inflammation-related indicators: high mobility group box-1 protein (HMGB1)
Time frame: up to 90 days
Days of ICU hospitalization
Time frame: up to 90 days
Total days of hospitalization
Time frame: up to 90 days
In-hospital survival rate
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation in people with Post-extubation Dysphagia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Jul 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuqin Feng (13757119151, fengxiuqin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional oral intake scale（FOIS） (time frame: up to 90 days). The study lists 2 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 1 Jul 2024.