Mechanical Ventilation Clinical Trial
Official title:
A Study on the Relationship Between Biodiversity of Intestinal Microbiota in Patients and Different Sedative-hypnotics Undergoing Mechanical Ventilation
Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. These patients often appear varying degrees of intestinal flora imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which exert negative effect on treatment and prolong hospitalization time.So far,whether the sedative drugs used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not has not been reported.The effects of different sedative drugs on the intestinal flora diversity need further study.Therefore, this topic will used midazolam and dexmedetomidine to study the effect on the diversity of intestinal microbiota.Meanwhile,the research will provide a theoretical basis for rational use of mechanical ventilation and sedative drugs.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 1, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients who receive long-term (=12 hours) mechanical ventilation after operation on admission to the ICU - APACHEII score 12-20 points - no receive other clinical trials in the near 3 months - no acute infectious disease, psychosis or other disease - volunteer people Exclusion Criteria: - known or suspected allergy to midazolam or Dexmedetomidine - suspected pregnancy, gross obesity, hyperlipemia, moribund state - history of alcoholism or intake of anti-anxiety drugs or hypnotics - chronic renal failure - coma by cranial trauma or neurosurgery or unknown etiology or status epilepticus - unwillingness to provide informed consent by patients or their authorized surrogates following ICU admission. |
Country | Name | City | State |
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China | Shanghai9 Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The changing trends of the diversity of Intestinal microbiota | Bacterial diversity revealed by 16S ribosomal RNA (rRNA) gene high-throughput sequencing (HTS).Feces were collected before operation from patients who had surgery.After the first collection, another was collected when the patient received mechanical ventilation more than 12 hours. | Up to 1 year from the beginning of the study | |
Secondary | The changing trends of weight | The changing trends of weight was recorded in kilograms by the experimental assistant | Up to 1 month from the beginning of the study | |
Secondary | duration of sedation | BIS and Ramsay score were described by the anesthetist physician | Time from achieving sedation until reaching full consciousness,up to 1 week. | |
Secondary | Duration of mechanical ventilation | Duration of mechanical ventilation was described by the anesthetist physician | Up to 3 days from the beginning of the study |
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