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

NCT07518680 | Not Yet Recruiting

• 1 other identifier: B2025-455R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in intra-abdominal pressure at each time point

  Baseline, during acupoint stimulation, and 30 minutes post-stimulation

• Oxygen saturation at each time point

  Baseline, during acupoint stimulation, and 30 minutes post-stimulation

• Blood pressure at each time point

  Baseline, during acupoint stimulation, and 30 minutes post-stimulation

• Heart rate at each time point

  Baseline, during acupoint stimulation, and 30 minutes post-stimulation

Study Arms (1)

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).

Other: Pressing the Tiantu acupoint to stimulate coughing

Interventions

Pressing the Tiantu acupoint to stimulate coughing OTHER

At the end of inhalation, press the Tiantu acupoint to stimulate coughing. The specific operation method has been mentioned earlier.

Pressing the Tiantu acupoint to stimulate coughing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Minjie Ju, ScD

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Minjie Ju, ScD

CONTACT

19180861785; 2943045720@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: April 8, 2026
• Study Start: April 10, 2026
• Primary Completion: May 10, 2026
• Study Completion: May 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CN (1)