Background
Methods/Design
Aim of study
Number of patients needed
Eligibility
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Age equal or greater than 18 years
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Patients scheduled for elective diagnostic EGDE without systemic sedation
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Patients classified ASA V
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Participation in another clinical trial which could interfere with the primary endpoint of this study
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Expected lack of compliance
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Impaired mental state or language problems
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Patients with known allergy to lidocaine anaesthetic spray or acupuncture needle material
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Necessity of systemic sedation
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Emergency procedures
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Pregnancy
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At their own request or at request of the legal representative
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If, in the investigator's opinion (physician performing the acupuncture or physician performing the examination), continuation of the trial would be detrimental to the subject's well-being (e.g. strong pain at the insertion points, allergical reactions, other independent acute health problems).
Consent
Randomization and procedures for minimizing bias
Minimizing bias
Minimizing treatment bias
Minimizing measurement bias
Study treatment
Day of screening and intervention | |
---|---|
Past medical history* | X |
Informed consent | X |
Personal data** | X |
Examination of primary endpoints: | X |
• Success of EGDE | |
Examination of secondary endpoints: | |
• Heart rate | X |
• Blood pressure | X |
• Oxygen saturation | X |
• Duration of examination | X |
• Willingness to repeat examination under same conditions | X |
• Periinterventional complications | X |
Safety criteria AE, SAE (2.6) | X |
According to the allocation the procedure will be continued
Intervention-group A (placebo acupuncture)
Intervention-group B (real acupuncture)
Primary and secondary endpoints
Primary endpoint
Definition of the primary endpoint
Assessment of the primary endpoint
Secondary endpoints
Complication | Definition |
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Haematoma | Clinical diagnosis |
Bleeding | Clinical diagnosis |
Nerve irritation | Clinical diagnosis |
Bradycardy | Heart rate < 60 beats per minute |
Hypotension | Blood pressure < 90 mmHg systolic |
Low oxygen saturation | Oxygen saturation < 92% |
Aspiration | Clinical diagnosis and radiological findings |
Wound infection | Clinical diagnosis |
Safety aspects
Specification of safety variables
Concomitant medication
Past medical history
Adverse events and serious adverse events
Analysis
Analysis sets
Confirmatory analysis
Further analysis
Homogeneity of the treatment groups
Study organization
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The incidence or severity of adverse events in this trial indicates a potential health hazard caused by the study treatment
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It appears that patient's enrolment is unsatisfactory with respect to quality or quantity or data recording is severely inaccurate or incomplete
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External evidence that renders the necessity to terminate the trial