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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Pressing the Tiantu acupoint to stimulate coughing

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Pressing the Tiantu acupoint to stimulate coughingExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline, during acupoint stimulation, and 30 minutes post-stimulation
2

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.

Time frame
Baseline, during acupoint stimulation, and 30 minutes post-stimulation
3

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.

Time frame
Baseline, during acupoint stimulation, and 30 minutes post-stimulation
4

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.

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

Other outcomes

Sponsors and contacts

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