Interventional Bronchoscopy Under Noninvasive Ventilation

Central Airway Stenosis Clinical Trial

Official title:

Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02289586
• Other study ID #: szkcw-2014-322
• Status: Recruiting
• Phase: N/A
• First received: August 4, 2014
• Last updated: November 12, 2014
• Start date: July 2014

Study information

• Verified date: August 2014
• Source: Futian People's Hospital
• Contact: Xiao-ke Chen, Master
• Phone: +86-755-83982222
• Email: 007cxk[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• invasive ventilation

• interventional bronchoscopy

Device:
• noninvasive ventilation

Drug:
• sedation(dezocine and midazolam)

• general anesthesia(midazolam, fentanyl,rocuronium,propofol and Remifentanil)

Locations

Country	Name	City	State
China	Futian People's Hospital	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Futian People's Hospital	Science and Technology Innovation Commission of Shenzhen Municipality

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement of airway stenosis after the operation		1 day	No
Primary	The improvement of partial pressure of arterial oxygen (PaO2) after the operation		1 day	No
Secondary	hospitalization expenses		During the period of hospitalization,an expected average of 4 weeks	No
Secondary	hypoxemia during the operation		1 day	Yes