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

Not Applicable

• Conditions: Anesthesia
• Interventions: Device: Vapotherm; Device: Apneic oxygenation

• Registration Number: NCT04885673
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2021-04-25
• Status Verified: 2021-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-13
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-18
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• We will include 64 patients planned for foreign body removal by rigid bronchoscope.
• All patients will be ASA І
• Recent FB aspiration in the last 72hrs either by history or documented by radiopaque shadow in chest X ray or CT scan.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (High flow nasal cannula group)	Vapotherm	(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 (Apeieoc oxygenation group)	Apneic oxygenation	The standard apneic oxygenation through the side port of rigid bronchoscope during the procedure

Primary Outcome Measures

Name	Time	Method
Maintain high level of oxygen saturation during the procedure	During the procedure time	Monitoring oxygen saturation by pulse oximeter and recording the readings

Trial Locations

Locations (1)

Samar Mohammed; 🇪🇬 Cairo, Egypt