Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy (PAPUA-Flow)
Primary Purpose
Apnoeic Oxygenation
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Oxygen
Sponsored by

About this trial
This is an interventional treatment trial for Apnoeic Oxygenation
Eligibility Criteria
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
Sites / Locations
- Bern University Hospital and University of Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-flow-nasal-cannula-therapy (HFNCT)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in ptcO2 and ptcCO2 in mmHg/min
Transcutaneous measurement
Upper airway patency
Flexible bronchoscopy will confirm upper airway patency: Open or closed
Changes in electrical impedance tomography. (EIT)
EIT will be continuously measured using PulmoVista® 500 visualizing possible atelectasis formation.
Full Information
NCT ID
NCT03738722
First Posted
November 6, 2018
Last Updated
October 1, 2019
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT03738722
Brief Title
Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy
Acronym
PAPUA-Flow
Official Title
Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
University of 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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnoeic Oxygenation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-flow-nasal-cannula-therapy (HFNCT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
High flow Oxygen
Intervention Description
HFNCT (high flow nasal cannula therapy) will be provided using OptiFlow by Fisher&Paykel.
Primary Outcome Measure Information:
Title
Mean positive airway pressure during Apnoea (approx.10 min) with HFNCT (High-Flow-Nasal-Cannula-Therapy)
Description
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
Time Frame
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 Measure Information:
Title
Changes in ptcO2 and ptcCO2 in mmHg/min
Description
Transcutaneous measurement
Time Frame
After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured
Title
Upper airway patency
Description
Flexible bronchoscopy will confirm upper airway patency: Open or closed
Time Frame
After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured
Title
Changes in electrical impedance tomography. (EIT)
Description
EIT will be continuously measured using PulmoVista® 500 visualizing possible atelectasis formation.
Time Frame
After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Riva, MD
Organizational Affiliation
University hospital of Bern
Official's Role
Principal Investigator
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
Undecided
Citations:
PubMed Identifier
26329355
Citation
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.
Results Reference
background
PubMed Identifier
25388828
Citation
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.
Results Reference
background
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
background
PubMed Identifier
21496369
Citation
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.
Results Reference
background
PubMed Identifier
22165366
Citation
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.
Results Reference
background
Learn more about this trial
Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy
We'll reach out to this number within 24 hrs