Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy (PAPUA-Flow)

Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates

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.

Study Overview

• Status: Completed
• Conditions: Apnoeic Oxygenation
• Intervention / Treatment: Drug: Oxygen

Detailed Description

Eligible adults with written informed consent will be monitored for general anaesthesia according standard operating procedure of the Bern University Hospital's anaesthesia department. Additional non-invasive monitoring for this study are transcutaneous measurement of carbon dioxide and oxygen (TCM 5®, Radiometer, Krefeld, Germany), NarcotrendTM ( Narcotrend-Group, Hannover, Germany)and thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany).

Normal pre-oxygenation (until end expiratory carbon dioxide is > 90% or time > 3 minutes) will occur. Anaesthesia will be started using a target -controlled infusion system for Propofol and Remifentanil, using NarcotrendTM to measure depth of anaesthesia. All patients will receive a standard dose of neuromuscular blockage to facilitate airway management and total intravenous anaesthesia will be installed. Using the train of four measurement (TOF) full neuromuscular blockage with Rocuronium will be confirmed every 30 seconds. After administration of rocuronium, proper bag-mask ventilation will be confirmed.

Intratracheal pressure will be measured by 11 Fr. catheter (Cook Medical, Bloomington, IN, USA), connected to a CODAN Xtrans®-transducer (CODAN ARGUS Ag, Baar, Switzerland). A 11 Fr. catheter (Cook Medical, Bloomington, IN, USA) will be introduced oral in the trachea facilitated by video-laryngoscopy. To ensure patency of the upper airway jaw thrust via Esmarch manoeuvre will be applied and flexible bronchoscopy will confirm upper airway patency. Initially this 11 Fr. catheter will be positioned in the right main bronchus (2 cm below the carina). The first measurement will be performed with a randomized sequence of flow rates of 80, 60, 40, 20 or 1 l/min with opened and closed mouth. Each pressure measurement will be performed after a stable pressure plateau of 10 seconds will be observed. The catheter will then be retracted and the pressure quantification are performed with the same sequence, defined above, in different positions (50% of trachea length and pharyngeal pressures 10 cm from upper front teeth). The order of flow and mouth opening will be randomized.

The study intervention will end when all measurements are taken or upper airway patency cannot be ensured under direct endoscopy view. If one of the following criteria is met: peripheral oxygen saturation (SpO2) <92% or transcutaneous carbon dioxide (PtCO2) >80mmHg, immediately bag mask ventilation will be initiated, until normal values of SpO2 and PtCO2 are reached.

When any of the end points is reached, normal anesthesiologic care will be established as planned.

A safety interview will be conducted on the first post-operative day to evaluate injuries during airway management (e.g. bleeding, sore throat, hoarseness, lip injuries), pain, postoperative nausea and vomiting.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3011
    • Bern University Hospital and University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Pregnancy (pregnancy test before inclusion)
• Neuromuscular disorder
• Known or suspected cervical spine instability
• Nasal obstruction, impossibility of nasal ventilation (both sides patent)
• Allergies or contra-indications to one or more of the used anaesthesia agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-flow-nasal-cannula-therapy (HFNCT); 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; HFNCT (high flow nasal cannula therapy) will be provided using OptiFlow by Fisher&Paykel.; Other Names: High flow Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ptcO2 and ptcCO2 in mmHg/min	Transcutaneous measurement	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	Flexible bronchoscopy will confirm upper airway patency: Open or closed	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)	EIT will be continuously measured using PulmoVista® 500 visualizing possible atelectasis formation.	After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: Principal Investigator: Thomas Riva, MD, University Hospital of Bern

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: ID 2018-01834

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No