Esophageal NeoplasmsNCT07518680
A Clinical Study on the Effect of Massaging Tian Tu Acupoint on Coughing After Esophageal Surgery
A study testing Pressing the Tiantu acupoint to stimulate coughing in people with Esophageal Neoplasms, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Pressing the Tiantu acupoint to stimulate coughing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and follow the requirements of the protocol;
- Age 18 to 75 years old (inclusive), gender not limited;
- Patients who have undergone esophageal surgery (without intubation);
- Not taking psychotropic drugs, mentally sound, and likely to cooperate in completing the assessment and intervention.
Who cannot join
- The subjects or their family members request to withdraw from the study;
- Pregnancy or lactation period;
- Severe heart and lung diseases (such as heart failure, acute exacerbation of COPD, asthma, etc.);
- Skin damage or infection in the area of the Tiantu acupoint;
- Within the last month, have received other cough-related interventions (such as acupuncture, physical therapy);
- Other situations that the researcher deems unsuitable for participating in this clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Minjie Ju, ScD, 19180861785, 2943045720@qq.com
About this study
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.
Read the 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.
- Conditions
- Esophageal Neoplasms
- Being tested
- Pressing the Tiantu acupoint to stimulate coughing
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressing the Tiantu acupoint to stimulate coughingOther
At the end of inhalation, press the Tiantu acupoint to stimulate coughing. The specific operation method has been mentioned earlier.
| Study group | Role | What they receive |
|---|---|---|
| Pressing the Tiantu acupoint to stimulate coughing | Experimental | 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). Receives: Other: Pressing the Tiantu acupoint to stimulate coughing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough peak expiratory flow rate at each time point
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.
Measured: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Secondary outcomes (4)
Change in intra-abdominal pressure at each time point
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.
Measured: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Oxygen saturation at each time point
Oxygen saturation (SpO2) recorded from the bedside patient monitor. It can indirectly assess the effectiveness of the patient's coughing after Tiantu acupoint stimulation.
Measured: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Blood pressure at each time point
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.
Measured: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Heart rate at each time point
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.
Measured: Baseline, during acupoint stimulation, and 30 minutes post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion10 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minjie Ju, ScD, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518680
- Sponsor's protocol ID
- B2025-455R
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Effect of Massaging Tian Tu Acupoint on Coughing After Esophageal Surgery
- ClinicalTrials.gov ID
- NCT07518680
- Acronym / sponsor ID
- B2025-455R
- Conditions
- Esophageal Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Apr 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressing the Tiantu acupoint to stimulate coughing | Experimental | Other: Pressing the Tiantu acupoint to stimulate coughingAt 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form and follow the requirements of the protocol;
- Age 18 to 75 years old (inclusive), gender not limited;
- Patients who have undergone esophageal surgery (without intubation);
- Not taking psychotropic drugs, mentally sound, and likely to cooperate in completing the assessment and intervention.
Key exclusion criteria (6 listed)
- The subjects or their family members request to withdraw from the study;
- Pregnancy or lactation period;
- Severe heart and lung diseases (such as heart failure, acute exacerbation of COPD, asthma, etc.);
- Skin damage or infection in the area of the Tiantu acupoint;
- Within the last month, have received other cough-related interventions (such as acupuncture, physical therapy);
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 |
|---|---|---|
| Pressing the Tiantu acupoint to stimulate coughingAt the end of inhalation, press the Tiantu acupoint to stimulate coughing. The specific operation method has been mentioned earlier. | Other | Pressing the Tiantu acupoint to stimulate coughing |
Primary outcome
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.
4 secondary outcomes
Change in intra-abdominal pressure at each time point
Time frame: 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
Blood pressure at each time point
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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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.
Minjie Ju, ScD study director
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressing the Tiantu acupoint to stimulate coughing in people with Esophageal Neoplasms, run by Shanghai Zhongshan Hospital 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 4 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: opening soon, as of the sponsor's last update on 8 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minjie Ju, ScD (19180861785, 2943045720@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough peak expiratory flow rate at each time point (time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation). 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 8 Apr 2026.