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

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: Not yet recruiting
• Conditions: Esophageal Neoplasms
• Intervention / Treatment: Other: Pressing the Tiantu acupoint to stimulate coughing

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minjie Ju, ScD; Phone Number: 19180861785; Email: 2943045720@qq.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital
      • Contact: Minjie Ju, ScD; Phone Number: 19180861785; Email: 2943045720@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	Baseline, during acupoint stimulation, and 30 minutes post-stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline, during acupoint stimulation, and 30 minutes post-stimulation

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Minjie Ju, ScD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID 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