Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

July 13, 2013 updated by: Duan jun, Chongqing Medical University

A Randomized Controlled Trial of Noninvasive Positive Pressure Ventilation for Weaning From Mechanical Ventilation in Tracheotomy Patients

The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively .If patients'conditions met our defined criterions, the investigators randomly allocate two groups. One group adopts traditional weaning strategy, the other adopts Noninvasive Positive Pressure Ventilation. If patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into Noninvasive Positive Pressure Ventilation. The investigators will extubate the tracheotomy tube, if patients are received Noninvasive Positive Pressure Ventilation more than 24 to 48 hours. After extubation, the investigators try to wean Noninvasive Positive Pressure Ventilation. Successful wean is defined weaning mechanical ventilation more than 48 hours.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital ,Chongqing Medical Univercity
      • Chongqing, Chongqing, China, 40016
        • The First Affiliated Hospital ,Chongqing Medical Univercity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 18 years
  • tracheotomy mechanical ventilation patients

Exclusion Criteria:

  • pregnancy
  • respiratory and hemodynamic instability
  • Recent oral，nasal，facial or cranial trauma or surgery
  • contra-indications for nasal or facial mask (facial skin lesions,...)
  • recent history of upper gastro-intestinal surgery
  • recent history of myocardial infarction
  • unconscious patients
  • non cooperative patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Noninvasive ventilation weaning
Patients in this group were weaned by noninvasive ventilation
Device: Noninvasive ventilation weaning
We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff
Other Names:
  • capping tracheotomy tube
No Intervention: Conventional weaning
Patients in this group were weaned by conventional stratiges.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Main end-point defined as total duration of mechanical ventilation
Time Frame: from admission to hospital to discharge from it or death
The total duration of mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
duration of invasive mechanical ventilation
Time Frame: from admission to hospital to discharge from it or death
The duration of invasive mechanical ventilation was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death
duration of extubation tracheotomy tube
Time Frame: from admission to hospital to discharge from it or death
The duration of extubation tracheotomy tube was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death
total duration of mechanical ventilation (invasive and non invasive)
Time Frame: from admission to hospital to discharge from it or death
The total duration of mechanical ventilation (invasive and non invasive) was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death
successful weaning rate
Time Frame: from admission to hospital to discharge from it or death
The sucessful weaning rate was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death
ICU length of stay
Time Frame: from admission to hospital to discharge from it or death
The ICU lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death
hospital length of stay
Time Frame: from admission to hospital to discharge from it or death
The hospital lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
from admission to hospital to discharge from it or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chongqing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Duan Jun, The First Affiliated Hospital,Chongqing Medical Univercity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQYKDXFSDYYY

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