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Clinical Trials/NCT02289586
NCT02289586
Unknown
Not Applicable

Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis

Futian People's Hospital1 site in 1 country40 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
invasive ventilation
Conditions
Noninvasive Positive Pressure Ventilation;
Sponsor
Futian People's Hospital
Enrollment
40
Locations
1
Primary Endpoint
The improvement of partial pressure of arterial oxygen (PaO2) after the operation
Last Updated
11 years ago

Overview

Brief Summary

To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis.

With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
February 2016
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Futian People's Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • (a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;

Exclusion Criteria

  • (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Arms & Interventions

hypoxemia, central airway stenosis.

Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Intervention: invasive ventilation

hypoxemia, central airway stenosis.

Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Intervention: interventional bronchoscopy

hypoxemia, central airway stenosis.

Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Intervention: general anesthesia(midazolam, fentanyl,rocuronium,propofol and Remifentanil)

hypoxemia, central airway stenosis

Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Intervention: interventional bronchoscopy

hypoxemia, central airway stenosis

Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Intervention: noninvasive ventilation

hypoxemia, central airway stenosis

Inclusion Criteria: * (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300; Exclusion Criteria: * (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.

Intervention: sedation(dezocine and midazolam)

Outcomes

Primary Outcomes

The improvement of partial pressure of arterial oxygen (PaO2) after the operation

Time Frame: 1 day

The improvement of airway stenosis after the operation

Time Frame: 1 day

Secondary Outcomes

  • hypoxemia during the operation(1 day)
  • hospitalization expenses(During the period of hospitalization,an expected average of 4 weeks)

Study Sites (1)

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