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

NCT04835272 | Unknown

• 1 other identifier: songlu20210320
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Tracheostomy Decannulation; Acquired Brain Injury

Keywords

Tracheostomy; Decannulation; without capping; Airway patency assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of decannulation failure

  within 1 week after decannulation

• high dependency unit length of stay

  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

  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

  follow-up six months after discharge

• Functional Independence Measure(FIM) six months after the acute brain injury

  follow up six months after discharge

Study Arms (2)

control group

NO INTERVENTION

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

intervention group

EXPERIMENTAL

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

Procedure: the Decannulation Protocol With Suctioning

Interventions

the Decannulation Protocol With Suctioning PROCEDURE

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.

Also known as: the Decannulation Protocol With Capping

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fu Xing Hospital, Capital Medical University: lead

Study Sites (1)

Fuxing hospital, capital medical university

Beijing, China

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Suction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Yong Wang

  Rehabilitation medicine center, Fuxing hospital, capital medical university

  STUDY CHAIR

Central Study Contacts

Lu Song

CONTACT

+86 15010852973; songlu@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: November 1, 2021
• Primary Completion: March 30, 2023
• Study Completion: October 30, 2023
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after publication

Locations

CN (1)