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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minjie Ju, ScD | Contact | 19180861785 | 2943045720@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Minjie Ju, ScD | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |