Improvement of Oxygenation During Apnoea by i-THRIVE (i-Thrive)
Primary Purpose
Preoxygenation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nasal oxygen flow
Sponsored by
About this trial
This is an interventional prevention trial for Preoxygenation focused on measuring Apnoea time, preoxygenation, difficult airway, emergency
Eligibility Criteria
Inclusion Criteria:
- 10-20 kg
- ASA 1+2
- Written informed consent
- Speaking German
Exclusion Criteria:
- Difficult intubation
- Oxygen dependency
- Congenital heart or lung disease
- BMI >30g/m2
- High aspiration risk
- nasal obstruction
Sites / Locations
- Bern University Hospital and University of Bern
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
High-flow 100% oxygen
Low-flow 100% oxygen
High-flow 30% oxygen
Arm Description
Nasal oxygen flow
Nasal oxygen flow
Nasal oxygen flow
Outcomes
Primary Outcome Measures
Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry
Secondary Outcome Measures
TcCO2mmHg level
TcO2mmHg level
Full Information
NCT ID
NCT02979067
First Posted
November 15, 2016
Last Updated
May 11, 2017
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02979067
Brief Title
Improvement of Oxygenation During Apnoea by i-THRIVE
Acronym
i-Thrive
Official Title
Improvement of Oxygenation During Apnoea by i-THRIVE (Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange): A Single-centre Prospective Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.
Detailed Description
High-Flow nasal cannula therapy is the administration of heated, humidified and blended air/oxygen via nasal cannula at rates of at least 2 L/kg bodyweight /min. This high-flow nasal cannula therapy was developed in neonatal intensive care unit for preterm babies with respiratory pauses as an alternative to continuous pressure support (CPAP). Due to its ease of use and safety to apply to a wide range of indication, this oxygen delivery therapy is increasingly gaining interest for providing respiratory support in paediatric and adult patients with respiratory failure in the ICU. High-flow nasal cannula therapy is applied in preterm infant with respiratory distress syndrome, apnoea of prematurity or a respiratory support after extubation. In the adult population the use of HFNCT focuses on hypoxemic respiratory failure and improvement reduction of hypoxemia during intubation in the anesthesia environment. A new application for high-flow nasal cannula therapy in adults is the extension of apnoea time in patients with difficult airways who are undergoing general anesthesia. In this environment a new term for this kind of oxygen therapy was created: THRIVE transnasal humidified rapid-insufflation ventilatory exchange. To distinguish this kind of high-flow nasal cannula therapy in apnoeic patients from the one in the paediatric ICU or ward the investigators use the term i-THRIVE for infant transnasal humidified rapid insufflation ventilation exchange.
Due to the increased oxygen consumption and the reduced functional residual capacity, neonates, infants, and small children have a reduced apnoea tolerance compared to adults. Furthermore infants and small children have a greater closing capacity, which increases the airway collapse under general anesthesia and muscle paralysis. A direct consequence is that hypoxemia is very likely to occur after cessation of spontaneous or assisted ventilation during induction of anesthesia. Apnoea without supplemental oxygen leads to hypoxemia in a 1-year-old infant without preoxygenation within seconds. All paediatric (and adult) patients undergoing general anesthesia have at least a brief period of apnoea during intubation between the time the face-mask is removed from the patient and the tube is placed in the trachea. Therefore, at least short phases of deoxygenation may occur.
However if anesthesia needs to be provided in emergency situations or in the presence of a difficult airway, the rate of complication increases rapidly. In these circumstances methods that reduce desaturation incidents during prolonged difficult intubation are desirable. Due to oxygen toxicity in neonates or small children, prevention of hypoxemia with oxygen concentration below 60% would be favourable in this setting. Despite promising pilot results with high-flow nasal cannula therapy, it is unknown whether this technique is superior to low-flow oxygenation with high concentration and whether it is necessary to apply high-flow nasal cannula therapy with high (80-100%) versus low (30-50%) concentration oxygen.
This study investigates under controlled circumstances the concept of i-THRIVE to prolong the apnoea time without deoxygenation and to improve safety of airway management in paediatric patients. Furthermore, this study enables to quantify the effects of different oxygen concentrations with high-flow nasal cannula therapy and distinguishes it better from conventional low-flow apnoeic oxygenation methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoxygenation
Keywords
Apnoea time, preoxygenation, difficult airway, emergency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-flow 100% oxygen
Arm Type
Active Comparator
Arm Description
Nasal oxygen flow
Arm Title
Low-flow 100% oxygen
Arm Type
Active Comparator
Arm Description
Nasal oxygen flow
Arm Title
High-flow 30% oxygen
Arm Type
Active Comparator
Arm Description
Nasal oxygen flow
Intervention Type
Procedure
Intervention Name(s)
Nasal oxygen flow
Intervention Description
Nasal oxygen flow during apnoea
Primary Outcome Measure Information:
Title
Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry
Time Frame
up to ten minutes during intervention
Secondary Outcome Measure Information:
Title
TcCO2mmHg level
Time Frame
study intervention, around 15 minutes
Title
TcO2mmHg level
Time Frame
study intervention, around 15 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
10-20 kg
ASA 1+2
Written informed consent
Speaking German
Exclusion Criteria:
Difficult intubation
Oxygen dependency
Congenital heart or lung disease
BMI >30g/m2
High aspiration risk
nasal obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Greif, MD MME FERC
Organizational Affiliation
University hospital Bern and University of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
Bern University Hospital and University of Bern
City
Bern
ZIP/Postal Code
3011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29452816
Citation
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.
Results Reference
derived
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Improvement of Oxygenation During Apnoea by i-THRIVE
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