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Effects of Different Ventilatory Strategy During Bronchoscopy

Sponsor
The First Affiliated Hospital of Guangzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05956301
Collaborator
(none)
150
Enrollment
3
Arms
23.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Conventional Oxygen Therapy
  • Device: High-flow nasal oxygen
  • Device: Supraglottic jet oxygenation and ventilation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Different Ventilatory Strategy During Bronchoscopy
Anticipated Study Start Date :
Jul 20, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group I

Conventional Oxygen Therapy

Device: Conventional Oxygen Therapy
Conventional Oxygen Therapy will be administered through Nasal catheter
Experimental: Group II

High-flow nasal oxygen

Device: High-flow nasal oxygen
High Flow Nasal Cannula will be administered
Experimental: Group III

Supraglottic jet oxygenation and ventilation

Device: Supraglottic jet oxygenation and ventilation
Nasal jet tube will be administered

Outcome Measures

Primary Outcome Measures

  1. Compare the intraoperative oxygenation. [During bronchoscopy, an average of 0.5 hour.]

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

Secondary Outcome Measures

  1. Arterial blood gases [At end of of bronchoscopy,an average of 0.5 hour after bronchoscope insertion.]

    Arterial blood gas analysis will be monitored at end of of procedure.

  2. Assess the regional ventilation distribution by Electrical impedance tomography . [During bronchoscopy, an average of 0.5 hour.]

    Measurements will be done after bronchoscope insertion and at the end of the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • need for bronchial endoscopy
Exclusion Criteria:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liya Lu, associate chief physician, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT05956301
Other Study ID Numbers:
  • 20230618
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 21, 2023