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Obesity, MorbidNCT03009877

Preoxygenation With Optiflow™ in Morbidly Obese Patients is Superior to Face Mask

A study testing Optiflow F&P 850™ System, facemask and Rocuronium in people with Obesity, Morbid, run by Montefiore Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. This study will examine whether Optiflow can do this, and compare the pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity, Morbid
What is being tested?
Optiflow F&P 850™ System, facemask and Rocuronium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2018to Dec 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

  • Adult patients (≥ 18 years old) undergoing elective surgery requiring general anesthesia
  • BMI > 40 kg/m2
  • American Society of Anesthesiology (ASA) Physical Status II-III

Who cannot join

  • Chronic hypoxemia (SpO2 <94% on room air or on home oxygen)
  • Acute respiratory failure
  • Coronary artery disease and/or congestive heart failure
  • Moderate-Severe pulmonary hypertension and/or RV dysfunction
  • Full stomach (recently eaten)
  • Pregnancy
Show all 10Show fewer
  • Chronic pulmonary disease (specifically COPD or interstitial disease, NOT asthma)
  • Respiratory tract pathology
  • Facial Abnormality
  • American Society of Anesthesiology (ASA) Physical Status IV-V

About this study

Official title: Preoxygenation With Optiflow™, a High Flow Nasal Cannula (HFNC), is Superior to Preoxygenation With Facemask in Morbidly Obese Patients Undergoing General Anesthesia

Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. This study will examine whether Optiflow can do this, and compare the pre-oxygenation with Optiflow to the pre-oxygenation achieved with face mask.

Read the detailed description

The use of high flow nasal cannula (HFNC) originated in neonatal care, and has become widespread in its application for patients that are high risk for hypoxemia, both in critical care and emergency settings. Therefore, high flow nasal oxygenation continues to be studied in airway management for preoxygenation, as well as maintenance of oxygenation in airway procedures. Optiflow™, a humidified high flow nasal cannula, has already been shown to be useful in preventing desaturation during intubation in ICU patients versus the non-rebreathing mask, in addition to, prolonging safe apnea time in patients with potential difficult airways. Additionally, preoxygenation with HFNC prior to intubation of patients in hypoxemic respiratory failure has also been shown to decrease desaturation during apnea compared to preoxygenation with traditional bag valve mask. The morbidly obese patient presents a separate group of challenges to the anesthesiologist in regards to mask ventilation and intubation. Obesity (along with other factors) has been shown to contribute to difficulty with mask ventilation. Obese patients have altered respiratory physiology, including decreased functional residual capacity, increased oxygen consumption and lower tidal volumes, as compared to the non-obese patient. These factors contribute to obese patients potentially having a shorter apnea time before desaturating during induction of general anesthesia, as compared to the non-obese patient. Weight is inversely correlated with safe apnea time. Optiflow™ may provide an opportunity to prolong apnea time in the morbidly obese patient population. If demonstrated to be efficacious as a method for preoxygenation and prolongation of apneic time, this could provide a safer environment for intubation in this particular patient population.

Conditions
Obesity, Morbid
Being tested
Optiflow F&P 850™ System, facemask, Rocuronium, Propofol, Fentanyl
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optiflow F&P 850™ SystemDevice

    Also called High flow nasal cannula

    Optiflow™ (Fisher \& Paykel Healthcare Limited, East Tamaki, Auckland-New Zealand) offers the ability to comfortably deliver a complete range of oxygen concentrations and flows to extend the traditional boundaries of oxygen therapy.

    This will be placed on the patient immediately upon entering the operating room for 5 minutes, at 50 liters per minute then increased to 70 liters per minute after induction.

  • facemaskDevice

    Also called face mask

    We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.

  • RocuroniumDrug

    Rocuronium will be administered after the ability to mask ventilate is determined.

  • PropofolDrug

    Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.

  • FentanylDrug

    Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.

  • MidazolamDrug

    Also called Versed

    midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.

  • C-MAC Premium Video Intubation Platform-KARL STORZDevice

    Also called videolaryngoscope and optical fiberoptic bronchoscope

    After patient is induced, the 5.5mm flexible intubation video scope (C-MAC Premium Video Intubation Platform-KARL STORZ) will then be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope (3 or 4 blade based on anesthesiologist's discretion).

Study groups in NCT03009877
Study groupRoleWhat they receive
Preoxygenation with face maskActive comparatorStandard preoxygenation with a mask will be performed for five minutes. Once preoxygenation is complete, patients will be induced with standard induction medications including lidocaine, midazolam, fentanyl and propofol. Once the patient is apneic, one breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. The 5.5mm flexible intubation scope will be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope. Once the flexible intubation scope is in the trachea, the endotracheal tube (7.0 mm unless otherwise specified) will be advanced. Ventilation will not begin until the primary or secondary endpoints are reached.
Receives: Device: facemask; Drug: Rocuronium; Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Device: C-MAC Premium Video Intubation Platform-KARL STORZ
Preoxygenation via hi flow nasal cannulaExperimentalThe high flow nasal cannula (Optiflow) will be applied as soon as the patient is in the operating room. The patient will be preoxygenated with high flow nasal cannula at 50 L/min for 5 minutes. After induction, general anesthesia will be maintained with a propofol infusion. One breath will be given via facemask to confirm ventilation and then 0.6 mg/kg of rocuronium will be administered. Upon apnea, the Optiflow™ flow will be increased to 70 L/min and jaw thrust will be performed until the patient is adequately relaxed. The video laryngoscope (C-MAC) will then be introduced into the oropharynx and the flexible intubation scope advanced into the trachea with the assistance of the C-MAC. Once the flexible intubation scope is in the trachea, the endotracheal tube will be advanced.
Receives: Device: Optiflow F&P 850™ System; Drug: Rocuronium; Drug: Propofol; Drug: Fentanyl; Drug: Midazolam; Device: C-MAC Premium Video Intubation Platform-KARL STORZ

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to desaturation

    Intraoperatively, apneic time will be record from the time of administration of the muscle relaxant. The time until the first desaturation will be recorded. The maximum time of measurement will be 10 minutes.

    Measured: up to 10 minutes

Secondary outcomes (2)

  1. Time until hypercarbia > 65 mmHg

    The time until hypercarbia to more than 65 mmHg will be measured from the time of administration of the muscle relaxant. The time until transcutaneous CO2 is > 65 mmHg will be recorded, unless 10 minutes is reached before that level is reached.

    Measured: up to 10 minutes

  2. Assess correlation between end tidal CO2 and transcutaneous CO2 monitoring

    Assessment of accurate correlation between transcutaneous CO2 monitoring, end tidal CO2, and/or PaCO2 will be performed up to 10 minutes.

    Measured: up to 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study startJul 2018 (estimated)
  3. Primary completionMay 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Why it stopped: withdrawn prior to IRB approval

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009877
Sponsor's protocol ID
2016-7360
Status last verified
Mar 2018
First submitted
21 Dec 2016
Last updated
27 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: This is a collaborative study, so the information will be shared with the researchers in Texas. However, we do not plan to use this information for other studies.

Publications

  • Locke RG, Wolfson MR, Shaffer TH, Rubenstein SD, Greenspan JS. Inadvertent administration of positive end-distending pressure during nasal cannula flow. Pediatrics. 1993 Jan;91(1):135-8.

    PubMed 8416477

  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

    PubMed 25981908

  • Hayes-Bradley C, Lewis A, Burns B, Miller M. Efficacy of Nasal Cannula Oxygen as a Preoxygenation Adjunct in Emergency Airway Management. Ann Emerg Med. 2016 Aug;68(2):174-80. doi: 10.1016/j.annemergmed.2015.11.012. Epub 2015 Dec 31.

    PubMed 26747218

  • Badiger S, John M, Fearnley RA, Ahmad I. Optimizing oxygenation and intubation conditions during awake fibre-optic intubation using a high-flow nasal oxygen-delivery system. Br J Anaesth. 2015 Oct;115(4):629-32. doi: 10.1093/bja/aev262. Epub 2015 Aug 7.

    PubMed 26253608

  • Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.

    PubMed 25529351

  • Miyagi K, Haranaga S, Higa F, Tateyama M, Fujita J. Implementation of bronchoalveolar lavage using a high-flow nasal cannula in five cases of acute respiratory failure. Respir Investig. 2014 Sep;52(5):310-4. doi: 10.1016/j.resinv.2014.06.006. Epub 2014 Jul 25.

    PubMed 25169847

  • Gottschalk A, Mirza N, Weinstein GS, Edwards MW. Capnography during jet ventilation for laryngoscopy. Anesth Analg. 1997 Jul;85(1):155-9. doi: 10.1097/00000539-199707000-00028.

    PubMed 9212140

  • Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.

    PubMed 25866645

  • 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.

    PubMed 25388828

  • Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

    PubMed 25003980

  • Aceto P, Perilli V, Modesti C, Ciocchetti P, Vitale F, Sollazzi L. Airway management in obese patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):809-15. doi: 10.1016/j.soard.2013.04.013. Epub 2013 May 6.

    PubMed 23810609

  • Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.

    PubMed 23836064

  • Sinha A, Jayaraman L, Punhani D. ProSeal LMA increases safe apnea period in morbidly obese patients undergoing surgery under general anesthesia. Obes Surg. 2013 Apr;23(4):580-4. doi: 10.1007/s11695-012-0833-7.

    PubMed 23361469

  • Jense HG, Dubin SA, Silverstein PI, O'Leary-Escolas U. Effect of obesity on safe duration of apnea in anesthetized humans. Anesth Analg. 1991 Jan;72(1):89-93. doi: 10.1213/00000539-199101000-00016.

    PubMed 1984382

  • Gambee AM, Hertzka RE, Fisher DM. Preoxygenation techniques: comparison of three minutes and four breaths. Anesth Analg. 1987 May;66(5):468-70. No abstract available.

    PubMed 3578856

Questions about this trial

What is this clinical trial studying?

A study testing Optiflow F&P 850™ System, facemask and Rocuronium in people with Obesity, Morbid, run by Montefiore Medical Center.

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 10 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: withdrawn, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Time to desaturation (time frame: up to 10 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 NCT03009877, which also lists 22 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 27 Mar 2018.

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