NCT02289586

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

November 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.6 years

First QC Date

August 4, 2014

Last Update Submit

November 12, 2014

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • The improvement of airway stenosis after the operation

    1 day

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

    1 day

Secondary Outcomes (2)

  • hospitalization expenses

    During the period of hospitalization，an expected average of 4 weeks

  • hypoxemia during the operation

    1 day

Study Arms (2)

hypoxemia, central airway stenosis.

ACTIVE COMPARATOR

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.

Procedure: invasive ventilationProcedure: interventional bronchoscopyDrug: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）

hypoxemia, central airway stenosis

EXPERIMENTAL

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.

Procedure: interventional bronchoscopyDevice: noninvasive ventilationDrug: sedation(dezocine and midazolam)

Interventions

invasive ventilationPROCEDURE
hypoxemia, central airway stenosis.
interventional bronchoscopyPROCEDURE
hypoxemia, central airway stenosishypoxemia, central airway stenosis.
noninvasive ventilationDEVICE
hypoxemia, central airway stenosis
sedation(dezocine and midazolam)DRUG
hypoxemia, central airway stenosis
general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）DRUG
hypoxemia, central airway stenosis.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (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;

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Futian People's Hospital

Shenzhen, Guangdong, 518033, China

RECRUITING

MeSH Terms

Interventions

Noninvasive VentilationMidazolamRemifentanil

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Xiao-ke Chen, Master

CONTACT

+86-755-83982222007cxk@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

November 13, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2016

Last Updated

November 13, 2014

Record last verified: 2014-08

Locations

CN(1)