Gastrointestinal Decompression, Pulmonary Infection, Stomach Acidity, Stroke
Conditions
Brief summary
Acute severe ischemic stroke is a life-threatening subtype of stroke. Due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. Reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. Gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. Early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. Therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.
Interventions
PROCEDUREGastrointestinal decompression
Gastric tube is inserted within 24-hour severe ischemic stroke attack; gastrointestinal decompression is performed for 48 hours.
PROCEDUREControl
Gastric tube is inserted within 24-hour severe ischemic stroke attack.
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * severe AIS, including NIHSS score\>20 in dominant hemisphere infarction, or NIHSS score\>15 in non-dominant hemisphere infarction, or NIHSS consciousness score \>1; · massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI * onset-to-needle time within 24 hours * prestroke modified Ranking scales (mRS)≤1 * sign the informed consent.
Exclusion criteria
* Recent respiratory infection and/or gastrointestinal bleeding * austere diseases such as tumors and dyscrasia * intention to undergo emergency thrombectomy * pregnant women or nursing mother * contraindication for gastric tubes * participating in other clinical trials within previous 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Death | 90 days | Death rate at 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mRS | 90 days | mRS at 90 days |
| 90-day Barthel scores | 90 days | Barthel scores at 90 days |
| 30-day mRS | 30 days | mRS at 30 days |
| 30-day Barthel scores | 30 days | Barthel scores at 30 days |
Contacts
Primary ContactJiayue Ding
Outcome results
None listed