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Interventional Bronchoscopy Under Noninvasive Ventilation

F

Futian People's Hospital

Status

Unknown

Conditions

Noninvasive Positive Pressure Ventilation;
Bronchoscopy;
Interventional;
Sedation;
Central Airway Stenosis

Treatments

Procedure: invasive ventilation
Drug: general anesthesia(midazolam, fentanyl,rocuronium,propofol and Remifentanil)
Device: noninvasive ventilation
Procedure: interventional bronchoscopy
Drug: sedation(dezocine and midazolam)

Study type

Interventional

Funder types

Other

Identifiers

NCT02289586
szkcw-2014-322

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

hypoxemia, central airway stenosis.
Active Comparator group
Description:
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.
Treatment:
Procedure: interventional bronchoscopy
Procedure: invasive ventilation
Drug: general anesthesia(midazolam, fentanyl,rocuronium,propofol and Remifentanil)
hypoxemia, central airway stenosis
Experimental group
Description:
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.
Treatment:
Procedure: interventional bronchoscopy
Device: noninvasive ventilation
Drug: sedation(dezocine and midazolam)

Trial contacts and locations

1

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Central trial contact

Xiao-ke Chen, Master

Data sourced from clinicaltrials.gov

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