Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy

NCT03738722 | Completed

• 1 other identifier: ID 2018-01834
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this explorative observational study is to investigate the pressures in infraglottic airway and the pharynx provided by THRIVE , using flows ranging from 1l/min to 80 l/min, in patients hospitalized for elective surgical procedure; to investigate the correlation between airway pressure and nasal oxygen flow.

Conditions

Apnoeic Oxygenation

Outcome Measures

Primary Outcomes (1)

• Mean positive airway pressure during Apnoea (approx.10 min) with HFNCT (High-Flow-Nasal-Cannula-Therapy)

  Measurement of the mean positive airway pressure in cm H2O during apnoea time in the pharynx (10cm distal upper front teeth), in the trachea (50% length) and in the right main bronchus (2cm distal carina), with different flow-rates (80l/min, 60l/min, 40l/min, 20l/min, 1l/min), with opened and closed mouth

  After induction of anaesthesia; Each pressure measurement (main bronchus,trachea, pharynx) will be performed after a stable pressure plateau of 10 sec. will be observed; until all measurements are taken or upper airway patency cannot be ensured

Secondary Outcomes (3)

• Changes in ptcO2 and ptcCO2 in mmHg/min

  After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured

• Upper airway patency

  After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured

• Changes in electrical impedance tomography. (EIT)

  After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured

Study Arms (1)

High-flow-nasal-cannula-therapy (HFNCT)

EXPERIMENTAL

100% Oxygen at 80 l/min with flow reductions of 20 l/min, jaw thrust, with opened and closed mouth, using different flow rates (80l/min, 60l/min, 40l/min, 20l/min, 1l/min) within each subject.

Drug: Oxygen

Interventions

Oxygen DRUG

HFNCT (high flow nasal cannula therapy) will be provided using OptiFlow by Fisher\&Paykel.

Also known as: High flow Oxygen

High-flow-nasal-cannula-therapy (HFNCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• Written informed consent
• Undergoing elective surgery
• Requiring general anesthesia
• ASA 1-3 (American Society of Anesthesiologists)

You may not qualify if:

• Any Indication for fibre optic intubation
• Expected impossible mask ventilation
• Known coronary heart disease
• Known heart failure, NYHA classification( New York Heart Association ) ≥ 2
• Peripheral occlusive arterial disease, Fontaine ≥ 2b
• BMI \> 30kg/m2 and BMI \< 16kg/m2
• Hyperkalaemia (K \> 5.5 mmol/l)
• Known COPD (Chronic obstructive pulmonary disease) Gold classification ≥ 2
• Known pulmonary arterial hypertension, systolic \> 35mmHg
• Known obstructive sleep apnoea syndrome in need of therapy
• High risk of aspiration
• Increased intracranial pressure
• Intracranial surgery
• Limited knowledge of German language
• Absent power of judgement

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Bern University Hospital and University of Bern

Bern, 3011, Switzerland

Location

Related Publications (5)

• Parke RL, Bloch A, McGuinness SP. Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers. Respir Care. 2015 Oct;60(10):1397-403. doi: 10.4187/respcare.04028. Epub 2015 Sep 1.

  PMID: 26329355 BACKGROUND

• Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

  PMID: 25388828 BACKGROUND

• 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: 29452816 BACKGROUND

• Parke RL, Eccleston ML, McGuinness SP. The effects of flow on airway pressure during nasal high-flow oxygen therapy. Respir Care. 2011 Aug;56(8):1151-5. doi: 10.4187/respcare.01106. Epub 2011 Apr 15.

  PMID: 21496369 BACKGROUND

• Ritchie JE, Williams AB, Gerard C, Hockey H. Evaluation of a humidified nasal high-flow oxygen system, using oxygraphy, capnography and measurement of upper airway pressures. Anaesth Intensive Care. 2011 Nov;39(6):1103-10. doi: 10.1177/0310057X1103900620.

  PMID: 22165366 BACKGROUND

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Thomas Riva, MD

  University hospital of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 13, 2018
• Study Start: January 10, 2019
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

CH (1)