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

NCT05672329 | Completed

• 1 other identifier: Fuchs-Riva2022
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 Minutes

Secondary Outcomes (7)

• Time until desaturation to SpO2 95%

  5 Minutes

• Changes in transcutaneous CO2

  5 Minutes

• Changes in brain oxygenation

  5 Minutes

• Changes in silent spaces and EELI after 1 min PSV

  5 Minutes

• Changes in silent spaces and EELI after airway management

  5 Minutes

Study Arms (4)

Group 1: Low-flow apnoeic oxygenation

EXPERIMENTAL

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

Other: 0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust

Group 2: High-flow apnoeic oxygenation

EXPERIMENTAL

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

Other: 2 L/kg/min, FiO2 1.0 + continuous jaw thrust

Group 3: Control group apnoeic oxygenation

ACTIVE COMPARATOR

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

Other: 4 L/kg/min, FiO2 1.0 + continuous jaw thrust

Group 4: High-flow apnoeic oxygenation

EXPERIMENTAL

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

Other: 2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrust

Interventions

0.2 L/kg/min, FiO2 1.0 + continuous jaw thrust OTHER

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

Group 1: Low-flow apnoeic oxygenation

2 L/kg/min, FiO2 1.0 + continuous jaw thrust OTHER

Apnoeic Oxygenation with flow rate 2 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0

Group 2: High-flow apnoeic oxygenation

4 L/kg/min, FiO2 1.0 + continuous jaw thrust OTHER

Apnoeic Oxygenation with flow rate 4 L/kg/min using OptiFlow system by Fisher\&Paykel and an oxygen inspiration concentration FiO2 of 1.0

Group 3: Control group apnoeic oxygenation

2 L/kg/min using OptiFlow-Switch system, FiO2 1.0 + continuous jaw thrust OTHER

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

Group 4: High-flow apnoeic oxygenation

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Known or suspected difficult intubation
• Oxygen dependency
• Congenital heart or lung disease
• Obesity BMI (kg/m2) \>30
• High aspiration risk (requiring rapid sequence intubation).

Sponsors & Collaborators

• Thomas Riva: lead

Study Sites (1)

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

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (1)

• Lippuner R, Pellaud C, Huber M, Greif R, Disma N, Riva T, Fuchs A, Riedel T. Efficacy of a lung recruitment manoeuvre in children undergoing general anaesthesia with a supraglottic airway. Br J Anaesth. 2025 Nov;135(5):1537-1542. doi: 10.1016/j.bja.2025.08.016. Epub 2025 Sep 23.

  PMID: 40993003 DERIVED

MeSH Terms

Conditions

Apnea; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander Fuchs, M.D.

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

  PRINCIPAL INVESTIGATOR

• Thomas Riva, M.D.

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

  STUDY DIRECTOR

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 INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 5, 2023
• Study Start: January 9, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 2, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)