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Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01900990
Enrollment
32
Registered
2013-07-17
Start date
2009-07-31
Completion date
2011-10-31
Last updated
2013-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

Noninvasive Positive Pressure Ventilation, Invasive Positive Pressure Ventilation, tracheotomy

Brief summary

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.

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.

Interventions

DEVICENoninvasive ventilation weaning

We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff

Sponsors

Chongqing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Main end-point defined as total duration of mechanical ventilationfrom admission to hospital to discharge from it or deathThe 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.

Secondary

MeasureTime frameDescription
duration of extubation tracheotomy tubefrom admission to hospital to discharge from it or deathThe 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.
total duration of mechanical ventilation (invasive and non invasive)from admission to hospital to discharge from it or deathThe 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.
duration of invasive mechanical ventilationfrom admission to hospital to discharge from it or deathThe 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.
ICU length of stayfrom admission to hospital to discharge from it or deathThe ICU lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
hospital length of stayfrom admission to hospital to discharge from it or deathThe hospital lentgh of stay was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.
successful weaning ratefrom admission to hospital to discharge from it or deathThe sucessful weaning rate was measured from the patient admitted to hospital to discharge from it or death, an expected average of 2 months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026