Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

June 28, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Jinhua, China
        • Recruiting
        • Jinhua Municipal Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
  2. aged from 18 to 90 years old;
  3. oral or nasotracheal intubation for ≥48 hours;
  4. Clear mind
  5. Glasgow score ≥13 points, with good cooperation ability;
  6. There was no contraindication to oral feeding after extubation

Exclusion Criteria:

  1. 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.);
  2. history of reflux and aspiration;
  3. tracheotomy;
  4. isolation treatment due to respiratory infectious diseases;
  5. the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
  6. Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
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.
Active Comparator: Comprehensive Intervention Group
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.
Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation
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.
Experimental: Comprehensive Intervention Combined with Vagus Nerve Stimulation Group
On the basis of the control group, a comprehensive intervention is implemented in combination with vagus nerve electrical stimulation.
Other: Comprehensive Intervention or Comprehensive Intervention Combined with Electrical vagus nerve stimulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 90 days
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.
up to 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of total oral feeding after the intervention
Time Frame: up to 90 days
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.
up to 90 days
Duration of Enteral Nutrition Tube Indwelling
Time Frame: up to 90 days
The duration of the nasogastric tube or nasointestinal tube indwelling in the patient
up to 90 days
Rate of Re-intubation after Endotracheal Intubation
Time Frame: up to 90 days
The rate of re-intubation during the intervention period after extubation in patients who have undergone endotracheal intubation
up to 90 days
Incidence of aspiration within one week after extubation
Time Frame: up to 90 days
Incidence of aspiration within one week after extubation
up to 90 days
The incidence of aspiration pneumonia within one week after extubation
Time Frame: up to 90 days
The incidence of aspiration pneumonia within one week after extubation
up to 90 days
Inflammation-related indicators: serum C-reactive protein (CRP)
Time Frame: up to 90 days
Monitoring of patients' inflammatory marker
up to 90 days
Inflammation-related indicators: serum interleukin-6 (IL-6)
Time Frame: up to 90 days
Monitoring of patients' inflammatory marker
up to 90 days
Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh)
Time Frame: up to 90 days
Monitoring of patients' inflammatory markers
up to 90 days
Inflammation-related indicators: high mobility group box-1 protein (HMGB1)
Time Frame: up to 90 days
Monitoring of patients' inflammatory marker
up to 90 days
Days of ICU hospitalization
Time Frame: up to 90 days
Days of ICU hospitalization
up to 90 days
Total days of hospitalization
Time Frame: up to 90 days
Total days of hospitalization
up to 90 days
In-hospital survival rate
Time Frame: up to 90 days
The number of patients who survive during hospitalization
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jinhua Municipal Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-1178

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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