PreoxygenationNCT03615417
High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia
A study testing High Flow Nasal Cannula (HFNC) and Standard anesthesia FaceMask (FM) in people with Preoxygenation and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoxygenation, Anesthesia, Obesity
- What is being tested?
- High Flow Nasal Cannula (HFNC) and Standard anesthesia FaceMask (FM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Apr 2018to 7 Sep 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgery with the need for general anesthesia with muscle relaxation
- ASA (American Society of Anesthesiologists) physical status score II-III
- BMI > 35
Who cannot join
- Severe respiratory disease (acute respiratory failure, Chronic obstructive pulmonary disease COPD, parenchymal pneumopathies,...)
- Severe nasal pathology (malformation, stenosis)
- Criteria or previous difficult intubation
- BMI > 50
- Chest circumference > 150cm
- Implanted electronic device (pacemaker, neurostimulator, ...)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia: A Randomised Controlled Trial
This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard procedure for obese induction.
The interest of HFNC preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.
- Conditions
- Preoxygenation, Anesthesia, Obesity
- Being tested
- High Flow Nasal Cannula (HFNC), Standard anesthesia FaceMask (FM)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal Cannula (HFNC)Device
Also called THRIVE, OptiFlow
Preoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth.
After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust.
At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.
Standard anesthesia FaceMask (FM)Device
Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O.
After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated.
| Study group | Role | What they receive |
|---|---|---|
| HFNC - High Flow Nasal Cannula | Experimental | Participants are preoxygenated by High Flow Nasal Cannula (HFNC) OptiFlow. Receives: Device: High Flow Nasal Cannula (HFNC) |
| FM - FaceMask | Active comparator | Participants are preoxygenated by standard anesthesia FaceMask. Receives: Device: Standard anesthesia FaceMask (FM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Residual Capacity (FRC) variation
The difference of FRC, estimated by lung Electrical Impedance Tomography (EIT), during general anesthesia induction (from a base period to the mechanical ventilation).
Measured: 20 minutes
Secondary outcomes (3)
Time of safe apnea
The time (seconds) of apnea following preoxygenation and muscle relaxation before to peripheral oxygen saturations (SpO2) decreases by 2%, or the apnea time reaches 600 seconds.
Measured: 20 minutes
Lowest SpO2
The lowest SpO2 (%) during general anesthesia induction (from a base period to the mechanical ventilation).
Measured: 20 minutes
Preoxygenation Comfort
The subjective comfort of the patient during the preoxygenation, expressed with a 0-5 scale at Post Anesthesia Care Unit (PACU) discharge.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start19 Apr 2018
- Primary completion7 Sep 2018
- Study completion7 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for PreoxygenationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Ricottilli, MD, Erasme University Hospital
- Investigators
- Francesco Ricottilli, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615417
- Sponsor's protocol ID
- SRB-201712-161
- Other IDs
- B406201834736, P2018/067
- Status last verified
- Nov 2018
- First submitted
- 30 Jul 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drake MG. High-Flow Nasal Cannula Oxygen in Adults: An Evidence-based Assessment. Ann Am Thorac Soc. 2018 Feb;15(2):145-155. doi: 10.1513/AnnalsATS.201707-548FR.
PubMed 29144160Okuda M, Tanaka N, Naito K, Kumada T, Fukuda K, Kato Y, Kido Y, Okuda Y, Nohara R. Evaluation by various methods of the physiological mechanism of a high-flow nasal cannula (HFNC) in healthy volunteers. BMJ Open Respir Res. 2017 Jul 20;4(1):e000200. doi: 10.1136/bmjresp-2017-000200. eCollection 2017.
PubMed 29071075Ang KS, Green A, Ramaswamy KK, Frerk C. Preoxygenation using the Optiflow system. Br J Anaesth. 2017 Mar 1;118(3):463-464. doi: 10.1093/bja/aex016. No abstract available.
PubMed 28203758White LD, Melhuish TM, White LK, Wallace LA. Apnoeic oxygenation during intubation: a systematic review and meta-analysis. Anaesth Intensive Care. 2017 Jan;45(1):21-27. doi: 10.1177/0310057X1704500104.
PubMed 28072931Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
PubMed 28035669Bauchmuller KB, Glossop AJ, De Jong A, Jaber S. Combining high-flow nasal cannula oxygen and non-invasive ventilation for pre-oxygenation in the critically ill: is a double-pronged approach warranted? : Discussion on article "Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial". Intensive Care Med. 2017 Feb;43(2):288-290. doi: 10.1007/s00134-016-4635-6. Epub 2016 Dec 8. No abstract available.
PubMed 27933345Jaber S, Monnin M, Girard M, Conseil M, Cisse M, Carr J, Mahul M, Delay JM, Belafia F, Chanques G, Molinari N, De Jong A. Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial. Intensive Care Med. 2016 Dec;42(12):1877-1887. doi: 10.1007/s00134-016-4588-9. Epub 2016 Oct 11.
PubMed 27730283Doyle AJ, Stolady D, Mariyaselvam M, Wijewardena G, Gent E, Blunt M, Young P. Preoxygenation and apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for emergency intubation. J Crit Care. 2016 Dec;36:8-12. doi: 10.1016/j.jcrc.2016.06.011. Epub 2016 Jun 23.
PubMed 27546740Ward JJ. High-flow oxygen administration by nasal cannula for adult and perinatal patients. Respir Care. 2013 Jan;58(1):98-122. doi: 10.4187/respcare.01941.
PubMed 23271822Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
PubMed 21908497Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
PubMed 19846404Kostic P, LoMauro A, Larsson A, Hedenstierna G, Frykholm P, Aliverti A. Specific anesthesia-induced lung volume changes from induction to emergence: a pilot study. Acta Anaesthesiol Scand. 2018 Mar;62(3):282-292. doi: 10.1111/aas.13026. Epub 2017 Nov 3.
PubMed 29105056Nimmagadda U, Salem MR, Crystal GJ. Preoxygenation: Physiologic Basis, Benefits, and Potential Risks. Anesth Analg. 2017 Feb;124(2):507-517. doi: 10.1213/ANE.0000000000001589.
PubMed 28099321Fraser JF, Spooner AJ, Dunster KR, Anstey CM, Corley A. Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end-expiratory lung volumes: a randomised crossover trial. Thorax. 2016 Aug;71(8):759-61. doi: 10.1136/thoraxjnl-2015-207962. Epub 2016 Mar 25.
PubMed 27015801Harbut P, Gozdzik W, Stjernfalt E, Marsk R, Hesselvik JF. Continuous positive airway pressure/pressure support pre-oxygenation of morbidly obese patients. Acta Anaesthesiol Scand. 2014 Jul;58(6):675-80. doi: 10.1111/aas.12317. Epub 2014 Apr 16.
PubMed 24738713
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High-Flow Nasal Cannula (HFNC) Preoxygenation in Obese Patients Undergoing General Anesthesia: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03615417
- Acronym / sponsor ID
- SRB-201712-161
- Conditions
- Preoxygenation, Anesthesia, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 7 Sep 2018 (actual)
- First posted
- 3 Aug 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.
This study aims to evaluate the effectiveness of the High Flow Nasal Cannula (HFNC) for the preoxygenation of obese patients undergoing a general anesthesia. The HFNC interface is compared to a standard anesthesia FaceMask (FM) preoxygenation with Continuous Positive Airway Pressure (CPAP), the current gold standard procedure for obese induction.
The interest of HFNC preoxygenation is to increase the "safe apnea time" before critical arterial desaturation, useful in the management of difficult airways, especially in subjects with reduced respiratory reserves such as the obese.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC - High Flow Nasal Cannula | Experimental | Device: High Flow Nasal Cannula (HFNC)Participants are preoxygenated by High Flow Nasal Cannula (HFNC) OptiFlow. |
| FM - FaceMask | Active comparator | Device: Standard anesthesia FaceMask (FM)Participants are preoxygenated by standard anesthesia FaceMask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Surgery with the need for general anesthesia with muscle relaxation
- ASA (American Society of Anesthesiologists) physical status score II-III
- BMI > 35
Key exclusion criteria (7 listed)
- Severe respiratory disease (acute respiratory failure, Chronic obstructive pulmonary disease COPD, parenchymal pneumopathies,...)
- Severe nasal pathology (malformation, stenosis)
- Criteria or previous difficult intubation
- BMI > 50
- Chest circumference > 150cm
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 |
|---|---|---|
| High Flow Nasal Cannula (HFNC)Also: THRIVE, OptiFlowPreoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth. After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated. | Device | HFNC - High Flow Nasal Cannula |
| Standard anesthesia FaceMask (FM)Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O. After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated. | Device | FM - FaceMask |
Primary outcome
Functional Residual Capacity (FRC) variation
Time frame: 20 minutes
The difference of FRC, estimated by lung Electrical Impedance Tomography (EIT), during general anesthesia induction (from a base period to the mechanical ventilation).
3 secondary outcomes
Time of safe apnea
Time frame: 20 minutes
Lowest SpO2
Time frame: 20 minutes
Preoxygenation Comfort
Time frame: 6 hours
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 19 Nov 2018.
- Background: PubMed 29144160Drake MG. High-Flow Nasal Cannula Oxygen in Adults: An Evidence-based Assessment. Ann Am Thorac Soc. 2018 Feb;15(2):145-155. doi: 10.1513/AnnalsATS.201707-548FR.
- Background: PubMed 29071075Okuda M, Tanaka N, Naito K, Kumada T, Fukuda K, Kato Y, Kido Y, Okuda Y, Nohara R. Evaluation by various methods of the physiological mechanism of a high-flow nasal cannula (HFNC) in healthy volunteers. BMJ Open Respir Res. 2017 Jul 20;4(1):e000200. doi: 10.1136/bmjresp-2017-000200. eCollection 2017.
- Background: PubMed 28203758Ang KS, Green A, Ramaswamy KK, Frerk C. Preoxygenation using the Optiflow system. Br J Anaesth. 2017 Mar 1;118(3):463-464. doi: 10.1093/bja/aex016. No abstract available.
- Background: PubMed 28072931White LD, Melhuish TM, White LK, Wallace LA. Apnoeic oxygenation during intubation: a systematic review and meta-analysis. Anaesth Intensive Care. 2017 Jan;45(1):21-27. doi: 10.1177/0310057X1704500104.
- Background: PubMed 28035669Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.
- Background: PubMed 27933345Bauchmuller KB, Glossop AJ, De Jong A, Jaber S. Combining high-flow nasal cannula oxygen and non-invasive ventilation for pre-oxygenation in the critically ill: is a double-pronged approach warranted? : Discussion on article "Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial". Intensive Care Med. 2017 Feb;43(2):288-290. doi: 10.1007/s00134-016-4635-6. Epub 2016 Dec 8. No abstract available.
- Background: PubMed 27730283Jaber S, Monnin M, Girard M, Conseil M, Cisse M, Carr J, Mahul M, Delay JM, Belafia F, Chanques G, Molinari N, De Jong A. Apnoeic oxygenation via high-flow nasal cannula oxygen combined with non-invasive ventilation preoxygenation for intubation in hypoxaemic patients in the intensive care unit: the single-centre, blinded, randomised controlled OPTINIV trial. Intensive Care Med. 2016 Dec;42(12):1877-1887. doi: 10.1007/s00134-016-4588-9. Epub 2016 Oct 11.
- Background: PubMed 27546740Doyle AJ, Stolady D, Mariyaselvam M, Wijewardena G, Gent E, Blunt M, Young P. Preoxygenation and apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for emergency intubation. J Crit Care. 2016 Dec;36:8-12. doi: 10.1016/j.jcrc.2016.06.011. Epub 2016 Jun 23.
- Background: PubMed 23271822Ward JJ. High-flow oxygen administration by nasal cannula for adult and perinatal patients. Respir Care. 2013 Jan;58(1):98-122. doi: 10.4187/respcare.01941.
- Background: PubMed 21908497Corley A, Caruana LR, Barnett AG, Tronstad O, Fraser JF. Oxygen delivery through high-flow nasal cannulae increase end-expiratory lung volume and reduce respiratory rate in post-cardiac surgical patients. Br J Anaesth. 2011 Dec;107(6):998-1004. doi: 10.1093/bja/aer265. Epub 2011 Sep 9.
- Background: PubMed 19846404Parke R, McGuinness S, Eccleston M. Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth. 2009 Dec;103(6):886-90. doi: 10.1093/bja/aep280. Epub 2009 Oct 20.
- Background: PubMed 29105056Kostic P, LoMauro A, Larsson A, Hedenstierna G, Frykholm P, Aliverti A. Specific anesthesia-induced lung volume changes from induction to emergence: a pilot study. Acta Anaesthesiol Scand. 2018 Mar;62(3):282-292. doi: 10.1111/aas.13026. Epub 2017 Nov 3.
- 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.
Francesco Ricottilli, MD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula (HFNC) and Standard anesthesia FaceMask (FM) in people with Preoxygenation and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
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 3 inclusion and 7 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 19 Nov 2018. 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 Belgium. 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?
Functional Residual Capacity (FRC) variation (time frame: 20 minutes). 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 NCT03615417, which also lists 20 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 19 Nov 2018.