Head Position After Endovascular Therapy
- Conditions
- Stroke, AcuteEndovascular Therapy
- Interventions
- Other: The lying flat (0°-10°) head position for 72 hoursOther: The The head elevation (30°-40°) position for 72 hours
- Registration Number
- NCT06115707
- Lead Sponsor
- Zhengzhou Yuan
- Brief Summary
The aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
- Detailed Description
The optimal head position for patients with acute ischemic stroke (AIS) remains uncertain. The HeadPoS study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. However, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median National Institutes of Health Stroke Scale score of 4). It is unclear how to arrange the patient's head position after endovascular treatment.
The hypothesis of this trial: Compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1332
- Clinical signs consistent with acute ischemic stroke;
- Age ≥ 18 years old;
- Proved anterior circulation large vessel occlusion on digital subtraction angiography (ICA, M1, M2) with/without cervical lesion (tandem);
- NIHSS score ≥ 8 points before endovascular treatment;
- ASPECTS score ≤ 7 points before endovascular treatment;
- Successful vessel recanalization after endovascular treatment (defined as an eTICI score of 2b, 2c, or 3) ；
- The time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time);
- Written informed consent is obtained from patients and/or their legal representatives.
- Pre-stroke mRS score>1 point;
- Patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation);
- Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- Contraindications to a flat head position;
- Any terminal illness with life expectancy less than 6 months;
- Participating in other clinical trials;
- Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Unlikely to be available for 90-day follow-up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The lying flat group The lying flat (0°-10°) head position for 72 hours Patients in lying flat intervention to be nursed lying flat (0°-10°) after endovascular therapy is made and to remain in this position for 72 hours. The head elevation group The The head elevation (30°-40°) position for 72 hours Patients in the sitting up intervention should be nursed with their head elevated (30°-40°) by raising the head of the bed (or using extra pillows or wedges) after undergoing endovascular therapy, and to remain in this position for 72 hours.
- Primary Outcome Measures
Name Time Method Modified Rankin scale score (mRS) 90 days disability level. The presence of impairments determines the transitions from mRS score 0 to mRS score 1 (symptoms) and mRS score 5 to mRS score 6 (death).
- Secondary Outcome Measures
Name Time Method Health-related quality of life, assessed with the EuroQol-visual analogue scales (EQ-VAS) 90 days Health-related quality of life
Symptomatic intracerebral hemorrhage incidence (Heidelberg Criteria) within 72 hours after randomized evaluate intracranial hemorrhage
Mortality within 90 days 90 days evaluate death rate of the two treatment groups
Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) 90 days excellent outcome
Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) 90 days ambulatory or bodily needs-capable or better
severe adverse events within 90 days evaluate complications and any adverse events
Incidence of pulmonary infections within 72 hours after randomized evaluate pulmonary infections
Proportion of patients functionally independent (mRS score 0 to 2) at 90 days Within 90 days90 days functional independence
Brain edema within 72 hours after randomized evaluate brain edema
Any type of intracerebral hemorrhage (Heidelberg Criteria) within 72 hours after randomized evaluate intracranial hemorrhage
Malignant Brain Edema within 72 hours after randomized evaluate brain edema
Improvement in National Institute of Health stroke scale (NIHSS) score between baseline and 5~7d at 5~7 days after randomization neurological changes.
Trial Locations
- Locations (67)
Guangdong Provincial People's Hospital Heyuan Hospital
🇨🇳Heyuan, Guangdong, China
The First People's Hospital of Chenzhou City
🇨🇳Chenzhou, Hunan, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Rizhao Traditional Chinese Medicine Hospital
🇨🇳Rizhao, Shandong, China
Chongqing Banan District People's Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Bishan District People's Hospital
🇨🇳Chongqing, Chongqing, China
Chongqing Ninth People's Hospital
🇨🇳Chongqing, Chongqing, China
Yongchuan Hospital Affiliated to Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
Longyan First Hospital
🇨🇳Longyan, Fujian, China
Scroll for more (57 remaining)Guangdong Provincial People's Hospital Heyuan Hospital🇨🇳Heyuan, Guangdong, ChinaYangchun WenContact86-0762-3185200