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Functional Residual Capacity Under Apnoeic Oxygenation With Different Flow Rates in Children (FUTURE)

Primary Purpose

Apnea, Anesthesia, Intubation Complication

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust
2 L/kg/min, FiO2 1.0 + continuous jaw thrust
4 L/kg/min, FiO2 1.0 + continuous jaw thrust
2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrust
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apnea focused on measuring Atelectasis, Apnoeic oxygenation, High-flow nasal oxygen, Silent spaces, Functional residual capacity, Paediatric anaesthesia

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent by legal guardian Paediatric patients undergoing elective surgery requiring general anaesthesia at the Bern University Hospital - Inselspital in Bern Child weight between 10-20kg American Society of Anesthesiology (ASA) physical status 1 & 2 (healthy child, no severe co-morbidities) Exclusion Criteria: Known or suspected difficult intubation Oxygen dependency Congenital heart or lung disease Obesity BMI (kg/m2) >30 High aspiration risk (requiring rapid sequence intubation).

Sites / Locations

  • Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of BernRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Group 1: Low-flow apnoeic oxygenation

Group 2: High-flow apnoeic oxygenation

Group 3: Control group apnoeic oxygenation

Group 4: High-flow apnoeic oxygenation

Arm Description

Group 1) 0.2 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0;

Group 2) 2 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0;

Group 3) 4 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0;

Group 4): 2 l/kg/min with OptiFlow FiO2 1.0 using OptiFlow-Switch system by Fisher&Paykel

Outcomes

Primary Outcome Measures

Total change in lung impedance
The total change in lung impedance measured in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT), normalized to the impedance amplitude during mechanical ventilation at 6-8 ml.kg-1 measured after 5 min of apnea compared to baseline measurement. Data given in percent (%) for silent spaces and delta EELI.

Secondary Outcome Measures

Time until desaturation to SpO2 95%
In case of desaturation within the predefined apnoea time: time (in seconds) until desaturation from peripheral saturation (SpO2) 100% to 95%, measured by peripheral pulse oximetry in percent (%).
Changes in transcutaneous CO2
Changes in transcutaneous carbon dioxide (tcCO2) in mmHg/min during apnoea time
Changes in brain oxygenation
Changes in brain oxygenation measured by near infrared spectroscopy (NIRS) during apnoea time given in percent (%)
Changes in silent spaces and EELI after 1 min PSV
The total change in lung impedance measured in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography, normalized to the impedance amplitude during mechanical ventilation at 6-8 ml.kg-1 after induction and 1 minute of pressure supported ventilation with backup frequency (PSV) at 6-8 ml/kg. Data given in percent (%) for silent spaces and delta EELI.
Changes in silent spaces and EELI after airway management
Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography after airway management (i.e. supraglottic airway or intubation). Data given in percent (%) for silent spaces and delta EELI.
Changes in silent spaces and EELI after recruitment manoeuvre
Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography after recruitment manoeuvre and 1 minute of mechanical ventilation at 6-8 ml/kg. Data given in percent (%) for silent spaces and delta EELI.
Time to 25%, 50% and 75% of total change in lung impedance
Time to 25%, 50% and 75% of total change in lung impedance by using electrical impedance tomography in seconds (s).

Full Information

First Posted
December 21, 2022
Last Updated
June 8, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05672329
Brief Title
Functional Residual Capacity Under Apnoeic Oxygenation With Different Flow Rates in Children
Acronym
FUTURE
Official Title
Functional Residual Capacity Under Apnoeic Oxygenation With Different Flow Rates in Children: A Single-centre Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
During induction of general anaesthesia physiological breathing stops and needs to be artificially established with facemask ventilation, and finally tracheal intubation or placement of a supraglottic airway. During the airway management, when lungs are not or only poorly ventilated, there is a risk for atelectasis. These atelectasis can contribute to respiratory adverse events (e.g. pulmonary infection or respiratory insufficiency) during or after general anaesthesia. High-flow nasal oxygen (HFNO) is the administration of heated, humidified and blended air/oxygen mixture via a nasal cannula at rates ≥ 2 L/kg/min. HFNO used during airway management (i.e. intubation) can extend the tolerance for apnea, the time from end of physiological breathing until artificial ventilation is established. The main objective of this study is thus to investigate the variations of poorly ventilated lung units (i.e., silent spaces) as a surrogate for functional residual capacity measured by electrical impedance tomography to dynamically assess atelectasis formation and regression under apnoeic oxygenation with different flow rates.
Detailed Description
High-flow nasal oxygen (HFNO) is the administration of heated, humidified and blended air/oxygen via nasal cannula at rates ≥ 2 L/kg/min. HFNO is an open system that can be used with nasal prongs of different sizes and was developed in neonatal intensive care unit for preterm babies with apnoea as alternative to continuous positive airway pressure (CPAP). Due to its ease of use and safety to apply to a wide range of indication HFNO is increasingly gaining interest for providing respiratory support in paediatric patients and in adults in ICU with respiratory failure. In adult populations, the use of HFNO permits to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. An application for HFNO in adults and children, is the extension of safe apnoea in patients who were undergoing general anaesthesia for hypopharyngeal or laryngo-tracheal surgery. This method, the so-called safe apnoeic oxygenation, also prevents hypoxemia in children during intubation. By using this technique, Patel et al. demonstrated a significate prolongation of apnoea time and proposed a ventilatory effect, as these studies revealed a slower increase in pCO2 than physiologically was expected. In these studies, researchers compared their data to studies from the 1950-ies, where CO2 increase during apnoea was investigated. In contrast, the investigators' previous research projects with HFNO did not confirm the claimed ventilatory effect in children and adults. Furthermore studies performed in spontaneously breathing neonates and adults have shown the ability of HFNO to generate some increase in pharyngeal pressure, which could explain the improvement of oxygenation despite prolongation of apnea time. The investigators' previous study on adult patients showed that a relevant increase of pressure was nearly absent while patient's mouth was open. Currently, there is no data on the physiological pressure that is generated in the subglottic airway in apneic children treated with HFNO. The traditional measurement of intratracheal pressure with a catheter in the trachea is considered to pose a risk in small children. The main objective of this study is thus to investigate the variations of poorly ventilated lung units (i.e., silent spaces) as a surrogate for functional residual capacity measured by electrical impedance tomography to dynamically assess atelectasis formation and regression under apnoeic oxygenation with different flow rates. Eligible children will receive premedication with Midazolam rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 30 minutes before the beginning of the procedure (local SOPs of the paediatric anaesthesia departments). Mandatory monitoring will consist of non-invasive peripheral oxygen saturation (SpO2), heartrate (HR), and non-invasive blood pressure (NIBP). An intravenous line for drugs injection will be placed. After start of anaesthesia (="induction"), adequate face-mask ventilation will be established. The sealed envelope for randomisation will then be opened. Standard anaesthesia will be continued using of intravenous propofol. Anaesthetic depth will be assessed using NarcotrendTM (NarcotrendTM, Hannover, Germany), maintaining values between 40 and 60. Additional study related non-invasive monitoring: transcutaneous tcCO2 and O2 (ToscaTM, Radiometer, Neuilly-Plaisance, France) measurement, thoracic electrical impedance tomography (EIT, PulmoVista 500, Draeger, Luebeck, Germany) and NIRS (Niro-200NX (Hamamatsu, Tokyo, Japan). ECG, pulse-oximetry, blood pressure, Narcotrend (NarcotrendTM, Hannover, Germany), thoracic EIT will be measured continuously, starting before induction while spontaneous breathing and ending 1 minute after the recruitment-manoeuvre. All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation dose) to facilitate airway management. Neuromuscular block will be assessed using train-of-four (TOF) monitoring (TOF-Watch, Organon Ltd, Dublin, Ireland). A TOF value of zero before apnoea start and throughout the whole procedure will be deemed essential. After that one minute of pressure support mask ventilation (Pmax 20 cm H20) with a backup respiratory rate of 20/min, normalized at a volume of 6-8 ml.kg-1 with 100% oxygen and will be applied. The ventilation will be discontinued, and the child will be left apnoeic for 5 minutes receiving oxygen according to the randomisation. Children will be randomized to receive three different flow rates of 100% oxygen, warmed and humidified with the OptiFlow device (Fisher&PaykelTM, Auckland, New Zealand): group 1): 0.2 l/kg/min + continuous jaw thrust group 2): 2 l/kg/min + continuous jaw thrust group 3): 4 l/kg/min + continuous jaw thrust (control group) Group 4): 2 l/kg/min with OptiFlow FiO2 1.0 using OptiFlow-Switch system by Fisher&Paykel. The nostrils must not be occluded by the nasal cannula by more than 50%. The time until desaturation from SpO2 100% to SpO2 95% will be measured. A chest ultrasound at end of intervention after definitive airway management will prove that no pneumothorax developed during the procedure. Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70 mmHg, or time of apnoea >5 minutes, a decrease of NIRS >30% from baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Anesthesia, Intubation Complication, Children, Only, Apnea Infant, Atelectasis, Ventilation Therapy; Complications
Keywords
Atelectasis, Apnoeic oxygenation, High-flow nasal oxygen, Silent spaces, Functional residual capacity, Paediatric anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Low-flow apnoeic oxygenation
Arm Type
Experimental
Arm Description
Group 1) 0.2 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0;
Arm Title
Group 2: High-flow apnoeic oxygenation
Arm Type
Experimental
Arm Description
Group 2) 2 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0;
Arm Title
Group 3: Control group apnoeic oxygenation
Arm Type
Active Comparator
Arm Description
Group 3) 4 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0;
Arm Title
Group 4: High-flow apnoeic oxygenation
Arm Type
Experimental
Arm Description
Group 4): 2 l/kg/min with OptiFlow FiO2 1.0 using OptiFlow-Switch system by Fisher&Paykel
Intervention Type
Other
Intervention Name(s)
0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust
Intervention Description
Apnoeic Oxygenation with flow rate 0.2 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0
Intervention Type
Other
Intervention Name(s)
2 L/kg/min, FiO2 1.0 + continuous jaw thrust
Intervention Description
Apnoeic Oxygenation with flow rate 2 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0
Intervention Type
Other
Intervention Name(s)
4 L/kg/min, FiO2 1.0 + continuous jaw thrust
Intervention Description
Apnoeic Oxygenation with flow rate 4 L/kg/min using OptiFlow system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0
Intervention Type
Other
Intervention Name(s)
2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrust
Intervention Description
Apnoeic Oxygenation with flow rate 2 L/kg/min using OptiFlow-Switch system by Fisher&Paykel and an oxygen inspiration concentration FiO2 of 1.0
Primary Outcome Measure Information:
Title
Total change in lung impedance
Description
The total change in lung impedance measured in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT), normalized to the impedance amplitude during mechanical ventilation at 6-8 ml.kg-1 measured after 5 min of apnea compared to baseline measurement. Data given in percent (%) for silent spaces and delta EELI.
Time Frame
5 Minutes
Secondary Outcome Measure Information:
Title
Time until desaturation to SpO2 95%
Description
In case of desaturation within the predefined apnoea time: time (in seconds) until desaturation from peripheral saturation (SpO2) 100% to 95%, measured by peripheral pulse oximetry in percent (%).
Time Frame
5 Minutes
Title
Changes in transcutaneous CO2
Description
Changes in transcutaneous carbon dioxide (tcCO2) in mmHg/min during apnoea time
Time Frame
5 Minutes
Title
Changes in brain oxygenation
Description
Changes in brain oxygenation measured by near infrared spectroscopy (NIRS) during apnoea time given in percent (%)
Time Frame
5 Minutes
Title
Changes in silent spaces and EELI after 1 min PSV
Description
The total change in lung impedance measured in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography, normalized to the impedance amplitude during mechanical ventilation at 6-8 ml.kg-1 after induction and 1 minute of pressure supported ventilation with backup frequency (PSV) at 6-8 ml/kg. Data given in percent (%) for silent spaces and delta EELI.
Time Frame
5 Minutes
Title
Changes in silent spaces and EELI after airway management
Description
Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography after airway management (i.e. supraglottic airway or intubation). Data given in percent (%) for silent spaces and delta EELI.
Time Frame
5 Minutes
Title
Changes in silent spaces and EELI after recruitment manoeuvre
Description
Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography after recruitment manoeuvre and 1 minute of mechanical ventilation at 6-8 ml/kg. Data given in percent (%) for silent spaces and delta EELI.
Time Frame
5 Minutes
Title
Time to 25%, 50% and 75% of total change in lung impedance
Description
Time to 25%, 50% and 75% of total change in lung impedance by using electrical impedance tomography in seconds (s).
Time Frame
5 Minutes

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent by legal guardian Paediatric patients undergoing elective surgery requiring general anaesthesia at the Bern University Hospital - Inselspital in Bern Child weight between 10-20kg American Society of Anesthesiology (ASA) physical status 1 & 2 (healthy child, no severe co-morbidities) Exclusion Criteria: Known or suspected difficult intubation Oxygen dependency Congenital heart or lung disease Obesity BMI (kg/m2) >30 High aspiration risk (requiring rapid sequence intubation).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Fuchs, M.D.
Phone
+4131 632 39 65
Email
alexander.fuchs@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Riva, M.D.
Phone
+4131 632 17 09
Email
thomas.riva@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Fuchs, M.D.
Organizational Affiliation
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Riva, M.D.
Organizational Affiliation
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital,
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Fuchs, M.D.
First Name & Middle Initial & Last Name & Degree
Thomas Riva, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Residual Capacity Under Apnoeic Oxygenation With Different Flow Rates in Children

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