NCT02979067

Brief Summary

Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 15, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

November 15, 2016

Last Update Submit

May 11, 2017

Conditions

Preoxygenation

Keywords

Apnoea time, preoxygenation, difficult airway, emergency

Outcome Measures

Primary Outcomes (1)

  • Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry

    up to ten minutes during intervention

Secondary Outcomes (2)

  • TcCO2mmHg level

    study intervention, around 15 minutes

  • TcO2mmHg level

    study intervention, around 15 minutes

Study Arms (3)

High-flow 100% oxygen

ACTIVE COMPARATOR

Nasal oxygen flow

Procedure: Nasal oxygen flow

Low-flow 100% oxygen

ACTIVE COMPARATOR

Nasal oxygen flow

Procedure: Nasal oxygen flow

High-flow 30% oxygen

ACTIVE COMPARATOR

Nasal oxygen flow

Procedure: Nasal oxygen flow

Interventions

Nasal oxygen flowPROCEDURE

Nasal oxygen flow during apnoea

High-flow 100% oxygenHigh-flow 30% oxygenLow-flow 100% oxygen

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1+2
  • Written informed consent
  • Speaking German

You may not qualify if:

  • Difficult intubation
  • Oxygen dependency
  • Congenital heart or lung disease
  • BMI \>30g/m2
  • High aspiration risk
  • nasal obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital and University of Bern

Bern, 3011, Switzerland

Location

Related Publications (1)

  • Riva T, Pedersen TH, Seiler S, Kasper N, Theiler L, Greif R, Kleine-Brueggeney M. Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):592-599. doi: 10.1016/j.bja.2017.12.017. Epub 2018 Jan 27.

    PMID: 29452816DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Greif, MD MME FERC

    University hospital Bern and University of Bern

    STUDY CHAIR

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

November 15, 2016

First Posted

December 1, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)