Esophageal Neoplasms
Conditions
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.
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.
Interventions
OTHERPressing 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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough peak expiratory flow rate at each time point | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in intra-abdominal pressure at each time point | 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. |
| Oxygen saturation at each time point | 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. |
| Blood pressure at each time point | 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. |
| Heart rate at each time point | 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. |
Countries
China
Contacts
CONTACTMinjie Ju, ScD
STUDY_DIRECTORMinjie Ju, ScD
Shanghai Zhongshan Hospital
Outcome results
None listed