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Interventional Bronchoscopy Under Noninvasive Ventilation

NCT ID: NCT02289586

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

invasive ventilation

Intervention Type PROCEDURE

interventional bronchoscopy

Intervention Type PROCEDURE

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

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

interventional bronchoscopy

Intervention Type PROCEDURE

noninvasive ventilation

Intervention Type DEVICE

sedation(dezocine and midazolam)

Intervention Type DRUG

Interventions

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invasive ventilation

Intervention Type PROCEDURE

interventional bronchoscopy

Intervention Type PROCEDURE

noninvasive ventilation

Intervention Type DEVICE

sedation(dezocine and midazolam)

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Science and Technology Innovation Commission of Shenzhen Municipality

OTHER

Sponsor Role collaborator

Futian People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Futian People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao-ke Chen, Master

Role: CONTACT

[email protected]
+86-755-83982222 ext. 32070

Facility Contacts

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Xiao-ke Chen, master

Role: primary

[email protected]
+86-755-83982222 ext. 32070

Other Identifiers

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szkcw-2014-322

Identifier Type: -

Identifier Source: org_study_id