Apneic Intubation Critically Ill Children

NCT04890288 | Unknown

• 1 other identifier: 2020-02609
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 7

Brief Summary

This study compares the actual standard of care of intubation in Swiss pediatric intensive care units vs the use of apneic oxygenation using either high flow or low flow oxygen to prevent hypoxemia and to prolong apnea time during intubation of critically ill children, with the final aim to improve airway management safety at PICUs. Primary study objective: To demonstrate that airway management supported by oxygen supplementation (either HFNC or low flow oxygen) can prevent significant desaturation (SpO2 \> 85%) among patients in pediatric intensive care units (PICU) and neonatal intensive care units (NICU).

Conditions

Airway Management

Keywords

Pediatric; Intubation; Apnea; Desaturation; High flow

Outcome Measures

Primary Outcomes (1)

• Number of patients with desaturation < 85 percent during intubation

  To demonstrate that airway management supported by oxygen supplementation (either HFNC or low flow oxygen) can prevent significant desaturation (SpO2 \> 85%) among patients in pediatric intensive care units (PICU) and neonatal intensive care units (NICU).

  15 minutes

Secondary Outcomes (6)

• Number of patients with desaturation low-flow oxygen vs. HFNC

  15 minutes

• First attempt success rate

  15 minutes

• Number of attempts

  15 minutes

• Time required for intubation

  5 minutes

• Duration of desaturation < 85 percent

  15 minutes

Study Arms (3)

Intervention group - High flow

EXPERIMENTAL

High-flow nasal cannula oxygen 2L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0; enabling apneic oxygenation during laryngoscopy.

Procedure: Interventional randomized controled trial (RCT) comparing two oxygenation methods to reduce desaturation during intubation vs standard of care.

Intervention group - Low flow:

EXPERIMENTAL

Low-flow oxygen (100%, 0.2 l/kg/min) via conventional neonatal nasal cannula (Intersurgical, Wokingham, Berkshire, United Kingdom) enabling apneic oxygenation during laryngoscopy.

Procedure: Interventional randomized controled trial (RCT) comparing two oxygenation methods to reduce desaturation during intubation vs standard of care.

Conventional

NO INTERVENTION

Conventionally practiced standard of care with preoxygenation with facemask with an FiO2 of 1.0, followed by bag mask ventilation after induction before oral intubation without apneic oxygenation.

Interventions

Interventional randomized controled trial (RCT) comparing two oxygenation methods to reduce desaturation during intubation vs standard of care. PROCEDURE

Demonstrate that airway management supported by oxygen supplementation (either HFNC or low flow oxygen) can prevent significant desaturation (SpO2 \> 85%) among patients in pediatric intensive care units (PICU) and neonatal intensive care units (NICU).

Intervention group - High flow; Intervention group - Low flow:

Eligibility Criteria

• Age: 37 Weeks - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients requiring intubation in the pediatric intensive care unit
• Aged from 37 weeks corrected gestational age to 6 years
• Legal guardians providing written informed consent before the intervention or delayed consent in the event that emergency intubation is required

You may not qualify if:

• Patients with known or suspected difficult/airways
• Congenital heart disease mandating FiO2 \< 1.0, warranting inhalational induction, requiring ongoing CPR or advanced life support due to respiratory arrest
• Preterm age \< 37 0/7 weeks
• Patients who cannot be intubated orally
• Respiratory insufficiency with an SpO2 saturation \< 90 % after 2 min of preoxygenation with FiO2 = 1.0
• Newborns requiring surfactant within the first 3 days of life
• Document stating intent to reject participation in research projects or refusal of intubation or refusal of resuscitation measures

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University Hospital, Geneva: collaborator
• State Hospital, St. Gallen: collaborator
• University of Zurich: collaborator
• Luzerner Kantonsspital: collaborator
• Kantonsspital Graubuenden: collaborator
• Ente Ospedaliero Cantonale, Bellinzona: collaborator

Study Sites (7)

EOC

Bellinzona, Switzerland

Location

Inselspital

Bern, Switzerland

Location

Kantonsspital

Chur, Switzerland

Location

HUG

Geneva, Switzerland

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Kinderspital

Sankt Gallen, Switzerland

Location

Kinderspital

Zurich, Switzerland

Location

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Riva, MD

  University of Berne

  STUDY CHAIR

Central Study Contacts

Francis F Ulmer, MD

CONTACT

+41316325265; francis.ulmer@insel.ch

Thomas Riva, MD

CONTACT

+41316321709; thomas.riva@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: May 18, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: June 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (7)