A Clinical Study on the Effect of Massaging Tian Tu Acupoint on Coughing After Esophageal Surgery

April 1, 2026 updated by: Shanghai Zhongshan Hospital
This study is a single-center, self-controlled trial. Patients will successively undergo voluntary coughing without intervention, a washout period, coughing stimulated by pressing the Tiantu acupoint, a washout period, and voluntary coughing without intervention. Vital signs of the patients before and after each cough will be recorded, as well as the changes in peak cough flow rate and intra-abdominal pressure after each cough. For peak cough flow rate and intra-abdominal pressure, three sets of data will be collected each time, and the best value will be taken. This pilot trial is conducted to verify the feasibility of the research design and to provide sample size estimation and data support for the main study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Detailed Description

This study is a single-center, self-controlled trial. Patients will successively undergo voluntary coughing without intervention, a washout period, coughing stimulated by pressing the Tiantu acupoint, another washout period, and voluntary coughing without intervention. Vital signs of the patients before and after each cough will be recorded, as well as the changes in peak cough flow rate and intra-abdominal pressure after each cough. Three sets of data will be collected for peak cough flow rate and intra-abdominal pressure each time, and the best value will be taken. The force, angle, and method of pressing are all specified with specific values. The finger pressure is measured by a pressure gauge at 1.59 to 3.45 N, each press lasts for 4 seconds, with an interval of 5 minutes, and is repeated three times. This pilot trial is conducted to verify the feasibility of the research design and provide sample size estimation and data support for the main study. It mainly focuses on patients after esophageal surgery to investigate whether pressing the Tiantu acupoint can effectively improve the coughing ability of patients.

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.
30

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
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan 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. Voluntarily sign the informed consent form and follow the requirements of the protocol;
  2. Age 18 to 75 years old (inclusive), gender not limited;
  3. Patients who have undergone esophageal surgery (without intubation);
  4. Not taking psychotropic drugs, mentally sound, and likely to cooperate in completing the assessment and intervention.

Exclusion Criteria:

  1. The subjects or their family members request to withdraw from the study;
  2. Pregnancy or lactation period;
  3. Severe heart and lung diseases (such as heart failure, acute exacerbation of COPD, asthma, etc.);
  4. Skin damage or infection in the area of the Tiantu acupoint;
  5. Within the last month, have received other cough-related interventions (such as acupuncture, physical therapy);
  6. Other situations that the researcher deems unsuitable for participating in this clinical trial

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: N/A
  • Interventional Model: Single Group 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.
Experimental: Pressing the Tiantu acupoint to stimulate coughing
At the end of the patient's inhalation, trained and qualified personnel with qualifications perform the compression. The right thumb or middle and index fingers are flexed and use the tips of the fingers to press on the patient's thyroid cartilage point (the thyroid cartilage point is located on the anterior midline of the neck, in the center of the supra-sternal fossa). Press vertically inward, with the tips of the fingers touching each other closely, aiming to cause itching in the throat. Stimulate the trachea to trigger a cough. The force should be at the minimum level that can produce a cough reflex. The pressure of the fingers is measured using a pressure gauge, which is 1.59 to 3.45 N. Each compression lasts for 4 seconds, with an interval of 5 minutes. Repeat this process 3 times (select the best value).
Other: Pressing the Tiantu acupoint to stimulate coughing
At the end of inhalation, press the Tiantu acupoint to stimulate coughing. The specific operation method has been mentioned earlier.

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
Cough peak expiratory flow rate at each time point
Time Frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
The maximum expiratory flow rate generated in the airway when coughing forcefully and rapidly. Measured by a portable peak flow meter sealed at the patient's mouth during coughing. It is a crucial and objective quantitative indicator for evaluating cough efficiency and the strength of the expiratory muscles.
Baseline, during acupoint stimulation, and 30 minutes post-stimulation

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
Change in intra-abdominal pressure at each time point
Time Frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
The change in intra-abdominal pressure is the key driving force for effective coughing and can be used to assess the strength of the cough. Measured by bladder manometry, the baseline value before coughing and the peak value during coughing are recorded, and the difference is calculated to assess cough strength.
Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Oxygen saturation at each time point
Time Frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Oxygen saturation (SpO2) recorded from the bedside patient monitor. It can indirectly assess the effectiveness of the patient's coughing after Tiantu acupoint stimulation.
Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Blood pressure at each time point
Time Frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Blood pressure recorded from the bedside patient monitor. Used to assess the safety of Tiantu acupoint stimulation by comparing hemodynamic fluctuations between stimulated and unstimulated coughing.
Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Heart rate at each time point
Time Frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Heart rate recorded from the bedside patient monitor. Used to assess the safety of Tiantu acupoint stimulation by comparing heart rate fluctuations between stimulated and unstimulated coughing.
Baseline, during acupoint stimulation, and 30 minutes post-stimulation

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.
Shanghai Zhongshan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Minjie Ju, ScD, Shanghai Zhongshan 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 (Estimated)

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.
April 10, 2026

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.
May 10, 2026

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.
May 31, 2026

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).
January 29, 2026

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 1, 2026

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 8, 2026

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.
April 8, 2026

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.
April 1, 2026

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, 2026

More Information

Terms related to this study

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.
  • B2025-455R

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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