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

Primary Purpose

Tracheostomy Decannulation, Acquired Brain Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the Decannulation Protocol With Suctioning
Sponsored by
Fu Xing Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheostomy Decannulation focused on measuring Tracheostomy, Decannulation, without capping, Airway patency assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fuxing hospital, capital medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention group

Arm Description

In the control group, the decision to decannulate was based on a 48-hour capping trial.

In the intervention group, the decision to decannulate was based on suctioning frequency.

Outcomes

Primary Outcome Measures

the time to decannulation
the time from randomization to actual decannulation

Secondary Outcome Measures

Rate of decannulation failure
reintubation within 1 week after decannulation
high dependency unit length of stay
the time from high dependency unit admission to rehabilitation ward
Rate of respiratory infections
post decannulation respiratory infections rate in each study group
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
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）.

Full Information

First Posted
March 29, 2021
Last Updated
October 9, 2021
Sponsor
Fu Xing Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04835272
Brief Title
Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients
Official Title
Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Xing Hospital, Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols: an assessment of readiness for decannulation that was based on suctioning frequency an assessment that was based on tracheostomy capping

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheostomy Decannulation, Acquired Brain Injury
Keywords
Tracheostomy, Decannulation, without capping, Airway patency assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
In the control group, the decision to decannulate was based on a 48-hour capping trial.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
In the intervention group, the decision to decannulate was based on suctioning frequency.
Intervention Type
Procedure
Intervention Name(s)
the Decannulation Protocol With Suctioning
Other Intervention Name(s)
the Decannulation Protocol With Capping
Intervention Description
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.
Primary Outcome Measure Information:
Title
the time to decannulation
Description
the time from randomization to actual decannulation
Time Frame
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 Measure Information:
Title
Rate of decannulation failure
Description
reintubation within 1 week after decannulation
Time Frame
within 1 week after decannulation
Title
high dependency unit length of stay
Description
the time from high dependency unit admission to rehabilitation ward
Time Frame
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
Title
Rate of respiratory infections
Description
post decannulation respiratory infections rate in each study group
Time Frame
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
Title
Glasgow Outcome Scale(GOS) six months after the acute brain injury
Description
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
Time Frame
follow-up six months after discharge
Title
Functional Independence Measure(FIM) six months after the acute brain injury
Description
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）.
Time Frame
follow up six months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Song
Phone
+86 15010852973
Email
songlu@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Wang
Organizational Affiliation
Rehabilitation medicine center, Fuxing hospital, capital medical university
Official's Role
Study Chair
Facility Information:
Facility Name
Fuxing hospital, capital medical university
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Wang
Phone
010-88062907
Email
wyrehabil@ccmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication are to be shared
IPD Sharing Time Frame
1 year after publication

Learn more about this trial

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

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