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NCT Number: NCT01900990

Noninvasive Positive Pressure Ventilation for Difficult Weaning 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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital ,Chongqing Medical Univercity, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noninvasive ventilation weaning

Device

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

Other names: capping tracheotomy tube

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2013
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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