CClinicalTrials.gg
Status unknownNCT04885673Updated May 18, 2021

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

An interventional study of Vapotherm and Apneic oxygenation in Anesthesia, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-05-18.

Sponsored by Ain Shams University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Anesthesia

Browse trials for

03

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Active comparator
    Group A (High flow nasal cannula group)

    (Vapotherm) will be used during the bronchoscopy time flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃

    Device: Vapotherm

  • Active comparator
    Group B (Apeieoc oxygenation group)

    The standard apneic oxygenation through the side port of rigid bronchoscope during the procedure

    Device: Apneic oxygenation

Interventions

  • DeviceVapotherm

    flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃

    Also known as: High flow nasal cannula

  • DeviceApneic oxygenation

    Standard apneic oxygenation through the side port of rigid bronchoscope during the procedure

05

What researchers measure

Primary outcomes

  1. Maintain high level of oxygen saturation during the procedure

    Monitoring oxygen saturation by pulse oximeter and recording the readings

    Time frame: During the procedure time

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT04885673
Lead sponsor
Ain Shams University
Responsible party
samar mohammed (Lecturer of Anesthesia, Ain Shams University) — Principal investigator
First posted
May 13, 2021
Start date
Apr 25, 2021
Primary completion
Jul 5, 2021 (estimated)
Completion
Jul 25, 2021 (estimated)
Last update
May 18, 2021

Study contacts

samar MD mohammed
Contact
dr_sm.md@hotmail.com
01006236494 ext. 002
Maha MD sadek
Contact
mahasadek81@yahoo.com
01144866675 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion