Apnoeic OxygenationPAPUA-FlowNCT03738722
Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates in Nasal Cannula Therapy
A study testing Oxygen in people with Apnoeic Oxygenation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apnoeic Oxygenation
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2019to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years
- Written informed consent
- Undergoing elective surgery
- Requiring general anesthesia
- ASA 1-3 (American Society of Anesthesiologists)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University Hospital and University of Bern
Bern, 3011
About this study
Official title: 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.
Read the 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.
- Conditions
- Apnoeic Oxygenation
- Being tested
- Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Also called High flow Oxygen
HFNCT (high flow nasal cannula therapy) will be provided using OptiFlow by Fisher\&Paykel.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Transcutaneous measurement
Measured: 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
Measured: 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.
Measured: After induction of anaesthesia, during apnoea period; until all pressure measurement (main bronchus,trachea, pharynx) are taken or upper airway patency cannot be ensured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start10 Jan 2019
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Apnoeic OxygenationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Thomas Riva, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738722
- Sponsor's protocol ID
- ID 2018-01834
- Acronym
- PAPUA-Flow
- Status last verified
- Oct 2019
- First submitted
- 6 Nov 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26329355Patel 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.
PubMed 25388828Riva 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.
PubMed 29452816Parke 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.
PubMed 21496369Ritchie 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.
PubMed 22165366
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Airway Pressure Under Apnoeic Oxygenation With Different Flow Rates
- ClinicalTrials.gov ID
- NCT03738722
- Acronym / sponsor ID
- PAPUA-Flow / ID 2018-01834
- Conditions
- Apnoeic Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-flow-nasal-cannula-therapy (HFNCT) | Experimental | Drug: Oxygen100% 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years
- Written informed consent
- Undergoing elective surgery
- Requiring general anesthesia
- ASA 1-3 (American Society of Anesthesiologists)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenAlso: High flow OxygenHFNCT (high flow nasal cannula therapy) will be provided using OptiFlow by Fisher\&Paykel. | Drug | High-flow-nasal-cannula-therapy (HFNCT) |
Primary outcome
Mean positive airway pressure during Apnoea (approx.10 min) with HFNCT (High-Flow-Nasal-Cannula-Therapy)
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
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
3 secondary outcomes
Changes in ptcO2 and ptcCO2 in mmHg/min
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
Upper airway patency
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
Changes in electrical impedance tomography. (EIT)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 26329355Parke 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.
- Background: PubMed 25388828Patel 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.
- Background: PubMed 29452816Riva 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.
- Background: PubMed 21496369Parke 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.
- Background: PubMed 22165366Ritchie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Riva, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Apnoeic Oxygenation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean positive airway pressure during Apnoea (approx.10 min) with HFNCT (High-Flow-Nasal-Cannula-Therapy) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738722, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.