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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Brain Injury; Tracheostomy Decannulation
• Intervention / Treatment: Procedure: the Decannulation Protocol With Suctioning

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lu Song; Phone Number: +86 15010852973; Email: songlu@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • FuXing Hospital, Capital Medical University
    • Contact: Yong Wang; Phone Number: 010-88062907; Email: wyrehabil@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; In the control group, the decision to decannulate was based on a 48-hour capping trial.
Experimental: intervention group; In the intervention group, the decision to decannulate was based on suctioning frequency.	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.; Other Names: the Decannulation Protocol With Capping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of decannulation failure	reintubation within 1 week after decannulation	within 1 week after decannulation
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
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
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
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

Collaborators and Investigators

• Sponsor: Fu Xing Hospital, Capital Medical University
• Investigators: Study Chair: Yong Wang, Rehabilitation medicine center, Fuxing hospital, capital medical university

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 9, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Tracheostomy; Decannulation; without capping; Airway patency assessment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: songlu20210320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication are to be shared
• IPD Sharing Time Frame: 1 year after publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No