Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients

Acquired Brain Injury Clinical Trial

Official title:

Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04835272
• Other study ID #: songlu20210320
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2021
• Source: Fu Xing Hospital, Capital Medical University
• Contact: Lu Song
• Phone: +86 15010852973
• Email: songlu[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:

1. an assessment of readiness for decannulation that was based on suctioning frequency

2. an assessment that was based on tracheostomy capping

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: October 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Within three months of onset

• Age=18 years old

• GCS=8

• Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)

• Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.

• Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.

• Without significant airway stenosis.

Exclusion Criteria:

• Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration

• Medical history of severe respiratory system or heart disease

• Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control

• Don't get informed consent from patient or guardian

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Procedure:
• the Decannulation Protocol With Suctioning
In the intervention group, the decision to decannulate was based on suctioning frequency. Patients underwent decannulation when they had had no more than two aspirations every 8 hours during during a 24-hour period. Patients in this group did not undergo capping trials.

Locations

Country	Name	City	State
China	Fuxing hospital, capital medical university	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to decannulation	the time from randomization to actual decannulation	From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	Rate of decannulation failure	reintubation within 1 week after decannulation	within 1 week after decannulation
Secondary	high dependency unit length of stay	the time from high dependency unit admission to rehabilitation ward	From the date of high dependency unit admission to transferring to rehabilitation ward, and the patients will be followed for the duration of high dependency unit stay, an expected average of 2 months
Secondary	Rate of respiratory infections	post decannulation respiratory infections rate in each study group	From the date of high dependency unit admission to hospital discharge, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary	Glasgow Outcome Scale(GOS) six months after the acute brain injury	The GOS is a brief descriptive outcome scale(from 0 point to 29 points, higher score means worse outcome). GOS six months after discharge to asess the prognosis of the patient	follow-up six months after discharge
Secondary	Functional Independence Measure(FIM) six months after the acute brain injury	The FIM is an 18-item ordinal scale, is viewed as most useful for assessment of progress during inpatient rehabilitation(from 18 points to 126 points, higher score means better outcome).	follow up six months after discharge