Effect of Intermittent Oral Enteral Nutrition Tube in Tracheostomized Patients With Intracerebral Hemorrhage
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Device: Intermittent Oro-esophageal Tube FeedingDevice: Nasogastric Tube Feeding
- Registration Number
- NCT06304051
- Lead Sponsor
- Muhammad
- Brief Summary
This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.
The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:
Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
Participants will be divided into two groups randomly, with different nutritional support respectively.
- Detailed Description
Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:
Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.
Participants will be divided into two groups randomly, with different nutritional support respectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 118
- meeting the diagnostic criteria for Intracerebral Hemorrhage.
- with placement of a tracheotomy tube.
- requiring enteral nutrition support.
- age over 18 years.
- able to cooperate with treatment and questionnaire investigation.
- combined with tumors in the head, neck, esophagus, or gastrointestinal tract
- an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus
- with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys
- with severe hemorrhagic disease or bleeding tendency;
- with dysphagia caused by non-stroke-related reasons in the past
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent Oro-esophageal Tube Feeding Intermittent Oro-esophageal Tube Feeding the nasogastric tube was removed, and Intermittent oro-esophageal tube feeding was initiated for nutrition support within 4 hours after completing the admission assessment, following the standard Intermittent oro-esophageal tube feeding procedure. Nasogastric Tube Nasogastric Tube Feeding This group was provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.
- Primary Outcome Measures
Name Time Method Number of cases of successful extubation day 30 The Number of tracheostomized patients for both groups was recorded and compared. The parameters or criteria for extubation were: 1) stable clinical condition and a respiratory rate of 12-22 breaths per minute. 2) strong coughing ability and minimal airway secretions. 3) after completing a trial of tracheostomy tube capping, patients showed no fever, dyspnea, or asthma within 72 hours. Additionally, their blood oxygen saturation remained above 95% and normal oxygen partial pressure was observed
- Secondary Outcome Measures
Name Time Method Clinical Pulmonary Infection Score day 1 and day 30 The Clinical Pulmonary Infection Score was recruited for evaluation, with specific assessment indicators such as body temperature, white blood cell count, respiratory secretions, chest X-rays, oxygenation index. The total scores ranged from 0 to 12, with a higher score indicated a more severe pulmonary infection
Hemoglobin level day 1 and day 30 Hemoglobin was recorded via blood routine test.(Hb, mg/L)
Serum albumin level day 1 and day 30 Serum albumin was recorded via blood routine test.(Alb, g/L)
Body mass index day 1 and day 30 Weight and height will be combined to report Body mass index in kg/m\^2
Trial Locations
- Locations (2)
Mingzhou Hos.
🇨🇳Huaibei, China
Fu shu afi. Hos.
🇨🇳Huabei, China