Effect of Intermittent Oro-esophageal Tube vs Nasogastric Tube in Tracheostomized Patients With Intracerebral Hemorrhage

Browse trials for

• Cerebral Hemorrhage 476
• Hemorrhage 3,000

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 118 is above the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Lead sponsor

Zeng Changhao is the lead sponsor of 59 studies on the registry; 26 are open to participants now.

Study arms

• Experimental
  The observation group

  The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control, and 2) comprehensive rehabilitation therapy including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture. For the observation group, 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.

  Behavioral: Basic treatment · Behavioral: comprehensive rehabilitation therapy · Device: Intermittent Oro-esophageal Tube Feeding

• Active comparator
  The control group

  The patients were provided with 1) basic treatment including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control, and 2) comprehensive rehabilitation therapy including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture. Patients in the control group were provided with nutrition support by the indwelling nasogastric tube. The entire feeding process strictly followed the standardized procedure for nasogastric feeding.

  Behavioral: Basic treatment · Behavioral: comprehensive rehabilitation therapy · Device: Nasogastric Tube Feeding

Interventions

• BehavioralBasic treatment

  including intracranial pressure reduction, anti-infection therapy, blood pressure and blood glucose control

• Behavioralcomprehensive rehabilitation therapy

  including respiratory tract management, care for tracheotomy tube, comprehensive training for hemiplegic limbs, swallowing function training, pulmonary function training, and acupuncture.

• DeviceIntermittent Oro-esophageal Tube Feeding

  The observation group was given enteral nutritional support with Intermittent Oro-esophageal Tube Feeding according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.

• DeviceNasogastric Tube Feeding

  The control group was given enteral nutritional support with Nasogastric Tube Feeding according to the relevant guidelines. Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient\'s cheek with medical tape. The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient\'s condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

Primary outcomes

1. Number of cases of successful extubation

   The Number of cases of successful extubation 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

   Time frame: day 30

Secondary outcomes

1. Body mass index

   Weight and height will be combined to report Body mass index in kg/m\^2

   Time frame: day 1 and day 30

2. Serum albumin

   Serum albumin was recorded via blood routine test.(Alb, g/L)

   Time frame: day 1 and day 30

3. Hemoglobin

   Hemoglobin was recorded via blood routine test.(Hb, mg/L)

   Time frame: day 1 and day 30

4. Clinical Pulmonary Infection Score

   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

   Time frame: day 1 and day 30

Individual participant data

Plan to share: No