NCT05956301

Brief Summary

The execution of diagnostic-therapeutic investigations by bronchial endoscopy can expose the patient to hypoxemia. For this reason, oxygen therapy is administered at low or high flows during the course of bronchoscopic procedures. Our study aim was to evaluate the efficacy and complications of High-flow nasal oxygen (HFNO) via Supraglottic jet oxygenation and ventilation (SJOV)during flexible bronchoscopy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

July 6, 2023

Last Update Submit

July 13, 2023

Conditions

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Compare the intraoperative oxygenation.

    The study will monitor the SpO2， heart rate(HR) and mean arterial pressure (MAP) during the procedure.

    During bronchoscopy, an average of 0.5 hour.

Secondary Outcomes (2)

  • Arterial blood gases

    At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.

  • Assess the regional ventilation distribution by Electrical impedance tomography .

    During bronchoscopy, an average of 0.5 hour.

Study Arms (3)

Group I

ACTIVE COMPARATOR

Conventional Oxygen Therapy

Device: Conventional Oxygen Therapy

Group II

EXPERIMENTAL

High-flow nasal oxygen

Device: High-flow nasal oxygen

Group III

EXPERIMENTAL

Supraglottic jet oxygenation and ventilation

Device: Supraglottic jet oxygenation and ventilation

Interventions

Conventional Oxygen TherapyDEVICE

Conventional Oxygen Therapy will be administered through Nasal catheter

Group I
High-flow nasal oxygenDEVICE

High Flow Nasal Cannula will be administered

Group II
Supraglottic jet oxygenation and ventilationDEVICE

Nasal jet tube will be administered

Group III

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • need for bronchial endoscopy

You may not qualify if:

  • life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks need for invasive or non invasive ventilation presence of pneumothorax or pulmonary enphisema or bullae recent (within 1 week) thoracic surgery presence of chest burns presence of tracheostomy pregnancy nasal or nasopharyngeal diseases dementia lack of consent or its withdrawal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Liya Lu

CONTACT

+86-020-830628852412183636@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 21, 2023

Study Start

July 20, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 21, 2023

Record last verified: 2023-07