AnesthesiaNCT04885673
High Flow Nasal Cannula in Comparison to Apneic Oxygenation During Foreign Body Removal by Rigid Bronchoscope
A study testing Vapotherm and Apneic oxygenation in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Vapotherm and Apneic oxygenation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2021to 25 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Samar Mohammed
Cairo, 11511
Samar Soliman, 01006236494, dr_sm.md@hotmail.com
Maha Sadek, 01144866675, mahasadek81@yahoo.com
About this study
To compare the effect of HFNC with standard apneic oxygenation on patient oxygenation and airway protection during foreign body removal by rigid bronchoscope.
Read the 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
- Conditions
- Anesthesia
- Being tested
- Vapotherm, Apneic oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VapothermDevice
Also called High flow nasal cannula
flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃
Apneic oxygenationDevice
Standard apneic oxygenation through the side port of rigid bronchoscope during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Group A (High flow nasal cannula group) | Active comparator | (Vapotherm) will be used during the bronchoscopy time flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃ Receives: Device: Vapotherm |
| Group B (Apeieoc oxygenation group) | Active comparator | The standard apneic oxygenation through the side port of rigid bronchoscope during the procedure Receives: Device: Apneic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintain high level of oxygen saturation during the procedure
Monitoring oxygen saturation by pulse oximeter and recording the readings
Measured: During the procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start25 Apr 2021
- Primary completion5 Jul 2021 (estimated)
- Study completion25 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samar mohammed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885673
- Sponsor's protocol ID
- FMASU R101/2021
- Status last verified
- May 2021
- First submitted
- 9 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula in Comparison to Apneic Oxygenation During Foreign Body Removal by Rigid Bronchoscope
- ClinicalTrials.gov ID
- NCT04885673
- Acronym / sponsor ID
- FMASU R101/2021
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 5 Jul 2021 (estimated)
- Study completion
- 25 Jul 2021 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (High flow nasal cannula group) | Active comparator | Device: 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) | Active comparator | Device: Apneic oxygenationThe standard apneic oxygenation through the side port of rigid bronchoscope during the procedure |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VapothermAlso: High flow nasal cannulaflow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃ | Device | Group A (High flow nasal cannula group) |
| Apneic oxygenationStandard apneic oxygenation through the side port of rigid bronchoscope during the procedure | Device | Group B (Apeieoc oxygenation group) |
Primary outcome
Maintain high level of oxygen saturation during the procedure
Time frame: During the procedure time
Monitoring oxygen saturation by pulse oximeter and recording the readings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vapotherm and Apneic oxygenation in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact samar MD mohammed (01006236494 ext. 002, dr_sm.md@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintain high level of oxygen saturation during the procedure (time frame: During the procedure time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.