Comparison of Oxygen Adminstration by Nasal Cannula and High Flow Cannula During Bronchoscopy

NCT03976167 | Completed

• 1 other identifier: IB 3150/16 PI
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized controled trial to compare oxygen desaturation during fiberoptic bronchoscopy using oxygen administered with nasal prongs and high flow nasal cannula. Drops in oxygen saturation are frequent during bronchoscopy and limit the procedure compromising patient security. The investigator's aim is to contribute to select better way of oxygen administration which could prevent desaturations during bronchoscopy in children.

Conditions

Respiratory Disease

Keywords

Children; Desaturations; Bronchoscopy; Oxygen; High flow oxygen

Outcome Measures

Primary Outcomes (1)

• Oxygen desaturation

  Number of patients with Oxygen saturation under 94% during bronchoscopy

  Trough study completion, an average of 2 years

Secondary Outcomes (5)

• Moderate oxygen desaturations

  Trough study completion, an average of 2 years

• Severe oxygen desaturations

  Trough study completion, an average of 2 years

• Tachypnea

  Trough study completion, an average of 2 years

• Apnea

  Trough study completion, an average of 2 years

• Bradycardia

  Trough study completion, an average of 2 years

Study Arms (2)

Common nasal cannula

ACTIVE COMPARATOR

Oxygen administration up to 4 liters according defined protocol

Device: Oxygen administration with Common nasal cannula

High flow nasal cannula

EXPERIMENTAL

Oxygen administered with high flow nasal cannula according child weight and protocol designed for this study

Device: Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel

Interventions

Oxygen administration with Common nasal cannula DEVICE

Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.

Common nasal cannula

Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel DEVICE

High flow nasal cannula

Eligibility Criteria

• Age: 29 Days - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• elective flexible bronchoscopy

You may not qualify if:

• admitted in Neonatal intensive care
• previous respiratory support: oxygen any device, non invasive or invasive ventilation
• patient who may benefit with continuous positive pressure during procedure

Sponsors & Collaborators

• Hospital Son Espases: lead

Related Publications (1)

• Sharluyan A, Osona B, Frontera G, Brandstrup KB, Figuerola J, Sanz-Ruiz I, Salas A, Garrido B, Eva CG, Fernandez A, Pena-Zarza JA, Gil JA, Bover-Bauza C, Sailer S. High flow nasal cannula versus standard low flow nasal oxygen during flexible bronchoscopy in children: A randomized controlled trial. Pediatr Pulmonol. 2021 Dec;56(12):4001-4010. doi: 10.1002/ppul.25655. Epub 2021 Sep 10.

  PMID: 34506689 DERIVED

MeSH Terms

Conditions

Respiration Disorders

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Study Officials

• Artur sharluyan, MD

  Ib-salut

  PRINCIPAL INVESTIGATOR

• Sebastian Sailer, MD

  Ib-salud

  STUDY DIRECTOR

• Francisco de Borja Osona Rodriguez, PhD

  Ib-salud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: November 10, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share