NCT04885673

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2021

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 9, 2021

Last Update Submit

May 14, 2021

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Maintain high level of oxygen saturation during the procedure

    Monitoring oxygen saturation by pulse oximeter and recording the readings

    During the procedure time

Study Arms (2)

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℃

Device: Vapotherm

Group B (Apeieoc oxygenation group)

ACTIVE COMPARATOR

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

Device: Apneic oxygenation

Interventions

VapothermDEVICE

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

Also known as: High flow nasal cannula
Group A (High flow nasal cannula group)
Apneic oxygenationDEVICE

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

Group B (Apeieoc oxygenation group)

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samar Mohammed

Cairo, 11511, Egypt

RECRUITING

Central Study Contacts

samar MD mohammed

CONTACT

01006236494dr_sm.md@hotmail.com

Maha MD sadek

CONTACT

01144866675mahasadek81@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 13, 2021

Study Start

April 25, 2021

Primary Completion

July 5, 2021

Study Completion

July 25, 2021

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations

EG(1)