Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning

NCT ID: NCT02921334

Last Updated: 2016-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-12-31

Brief Summary

The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.

Detailed Description

When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.

Conditions

Ventilator Weaning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Patients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation.

Group Type: EXPERIMENTAL

switching between invasive and noninvasive ventilation

Intervention Type: PROCEDURE

As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.

Control group

Patients in this group are weaned from ventilator as conventional methods.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

switching between invasive and noninvasive ventilation

As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• duration of invasive ventilation 5 to 7 days
• anticipation of difficult weaning
• Glasgow Coma Scale ≥13
• no upper airway obstruction
• presence of spontaneous breath

Exclusion Criteria

• age less than 18 or more than 85 years;
• contraindications for noninvasive ventilation;
• anticipation of survival less than 6 months;
• refusal of tracheotomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Duan jun

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuliang Guo, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Chongqing Medical University

Locations

The first affiated hospital, chongqing medical university

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guosheng Ren, MD

Role: CONTACT

02389012680

Facility Contacts

Jun Duan

Role: primary

duanjun412589@163.com

86-023-89012680

Other Identifiers

cqykdxfsdyyy3

Identifier Type: -

Identifier Source: org_study_id