About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Pressing the Tiantu acupoint to stimulate coughing
Other interventionAt the end of inhalation, press the Tiantu acupoint to stimulate coughing. The specific operation method has been mentioned earlier.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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