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NCT04885673 Clinical Trial

High Flow Nasal Cannula in Comparison to Apneic Oxygenation During Foreign Body Removal by Rigid Bronchoscope

Anesthesia Clinical Trial

Official title:
High Flow Nasal Cannula in Comparison to Apneic Oxygenation During Foreign Body Removal by Rigid Bronchoscope

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04885673
Other study ID # FMASU R101/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2021
Est. completion date July 25, 2021

Study information
Verified date May 2021
Source Ain Shams University
Contact samar MD mohammed
Phone 01006236494
Email dr_sm.md@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the effect of HFNC with standard apneic oxygenation on patient oxygenation and airway protection during foreign body removal by rigid bronchoscope.

Description:

This study is a prospective, randomized controlled trial, at Ain Shams University hospitals, Cardiovascular surgery hospital (Thoracic surgery unit), Cairo, Egypt. We will include 64 patients planned for foreign body removal by rigid bronchoscope. All patients will be ASA І with recent FB aspiration in the last 72hrs either by history or documented by radiopaque shadow in chest X ray or CT scan. After achievement of anesthesia and full muscle relaxation ventilation started by open mask technique. Then the patients will be divided into two groups according to the oxygenation technique: Group (A) (32 patients) HFNC (Vapotherm) will be used during the bronchoscopy time flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃ . Group (B) (32 patients) (control group) using the standard apneic oxygenation through the side port of rigid bronchoscope during the procedure

Recruitment information / eligibility
Status Recruiting
Enrollment 64
Est. completion date July 25, 2021
Est. primary completion date July 5, 2021
Accepts healthy volunteers No
Gender All
Age group 10 Years to 40 Years
Eligibility Inclusion Criteria: - We will include 64 patients planned for foreign body removal by rigid bronchoscope. - All patients will be ASA ? - Recent FB aspiration in the last 72hrs either by history or documented by radiopaque shadow in chest X ray or CT scan. Exclusion Criteria: - Patients age not more than 40 years old. - Body weight less than 40 kg. - Critically ill patients. - Intubated patients. - Inhalation of FB more than 72 hrs.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Vapotherm
flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38?
• Apneic oxygenation
Standard apneic oxygenation through the side port of rigid bronchoscope during the procedure

Locations
Country Name City State
Egypt Samar Mohammed Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maintain high level of oxygen saturation during the procedure Monitoring oxygen saturation by pulse oximeter and recording the readings During the procedure time
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