Apneic OxygenationNCT02943629
A "Less-rapid" Sequence Anesthetic Induction/Intubation Sequence? Does Apneic Oxygenation by Means of an Oxygenating Laryngoscope Blade Prolong the "Duration of Apnea Without Desaturation" in Paralyzed Non-obese and Morbidly Obese Patients?
A study testing Apneic oxygenation: Eight minute, Without apneic oxygenation and Apneic oxygenation: five minutes in people with Apneic Oxygenation, run by Vanderbilt University.
Trial summary
The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Apneic Oxygenation
- What is being tested?
- Apneic oxygenation: Eight minute, Without apneic oxygenation and Apneic oxygenation: five minutes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 1 Apr 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients,
- American Society of Anesthesiologists Rating 1-2,
- Aged 18 through 65 years of age
- Elective gynecological surgery via an abdominal approach (laparoscopic or open)
- Already consented to general anesthesia necessitating endotracheal intubation.
- Are candidates for anesthesia using laryngeal mask airway if needed
Who cannot join
- Patient refusal to enter study
- History of difficult mask ventilation
- History of, or anticipated difficult intubation
- Heavy Smokers (> 10 cigarettes per day)
- Asthma
- Chronic Obstructive Pulmonary Disease
Show all 12Show fewer
- Heart Disease
- Renal or Liver disease
- Neurological disease.
- Women scored at ≥ 3/4 on the modified Mallampati scale 30.
- Women exhibiting other signs of a potential difficult intubation (limited neck flexion or extension; neck circumference > 30 cm; prominent incisors)
- Patients with a baseline resting oxygenation level of less than 95%.
About this study
The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females.
Read the detailed description
Pre-oxygenation/de-nitrogenation for three minutes of spontaneous breathing or alternatively four to eight deep breaths prior to rapid sequence anesthetic induction/intubation (RSII) in patients with healthy lungs, low oxygen demands and normal hemoglobin levels allows up to eight minutes of safe apnea time or DAWD.
The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade as the means to provide apneic oxygenation and prolong DAWD. The P Blade sports a suction conduit which can equally well provide a conduit for oxygen administration. The initial phase of the study will include non-obese healthy (ASAR 1-2) women patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery. Subsequently a cohort of morbidly obese patients (BM I ≥ 40 kg/m2) also requiring gynecologic abdominal access will be recruited for investigation.
Participants of each group (obese, non-obese) will be randomized to apneic oxygenation with the the Pentax AWS Laryngoscope or no apneic oxygenation.
- Conditions
- Apneic Oxygenation
- Being tested
- Apneic oxygenation: Eight minute, Without apneic oxygenation, Apneic oxygenation: five minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic oxygenation: Eight minuteDevice
A Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for eight minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.
Without apneic oxygenationDevice
A Pentax AWSTM video laryngoscope with attached P blade will be placed for eight minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.
Apneic oxygenation: five minutesDevice
A Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for five minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.
| Study group | Role | What they receive |
|---|---|---|
| Non-Obese: Apneic Oxygenation: eight minute | Experimental | Non-obese healthy female patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed and then receive 10 l/minute flow of oxygen through the P blade (apneic oxygenation) for eight minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. Receives: Device: Apneic oxygenation: Eight minute |
| Non-Obese: Without Apneic Oxygenation | Other | Non-obese healthy female patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed for eight minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. Receives: Device: Without apneic oxygenation |
| Obese: Apneic Oxygenation: five minute | Experimental | Morbidly obese patients (BM I ≥ 40 kg/m2) requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed and then receive 10 l/minute flow of oxygen through the P blade (apneic oxygenation) for five minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. Receives: Device: Apneic oxygenation: five minutes |
| Obese: Without Apneic Oxygenation | Other | Morbidly obese patients (BM I ≥ 40 kg/m2) requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed for five minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. Receives: Device: Without apneic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of apnea without desaturation
Measured: Time in seconds from the initiation of laryngoscopy until the time at which Sp02 falls to 95%, or until 8 minutes have elapsed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Why it stopped: Lack of feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Apneic OxygenationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Curtis Baysinger, Vanderbilt University
- Investigators
- Curtis Baysinger, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943629
- Sponsor's protocol ID
- 160579
- Status last verified
- May 2019
- First submitted
- 20 Oct 2016
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
FRUMIN MJ, EPSTEIN RM, COHEN G. Apneic oxygenation in man. Anesthesiology. 1959 Nov-Dec;20:789-98. doi: 10.1097/00000542-195911000-00007. No abstract available.
PubMed 13825447Paolini JB, Donati F, Drolet P. Review article: video-laryngoscopy: another tool for difficult intubation or a new paradigm in airway management? Can J Anaesth. 2013 Feb;60(2):184-91. doi: 10.1007/s12630-012-9859-5. Epub 2012 Dec 12.
PubMed 23233395Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
PubMed 19399574Jense 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 1984382Shah U, Wong J, Wong DT, Chung F. Preoxygenation and intraoperative ventilation strategies in obese patients: a comprehensive review. Curr Opin Anaesthesiol. 2016 Feb;29(1):109-18. doi: 10.1097/ACO.0000000000000267.
PubMed 26545146Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
PubMed 22050948De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.
PubMed 25431308Gebremedhn EG, Mesele D, Aemero D, Alemu E. The incidence of oxygen desaturation during rapid sequence induction and intubation. World J Emerg Med. 2014;5(4):279-85. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.007.
PubMed 25548602Altermatt FR, Munoz HR, Delfino AE, Cortinez LI. Pre-oxygenation in the obese patient: effects of position on tolerance to apnoea. Br J Anaesth. 2005 Nov;95(5):706-9. doi: 10.1093/bja/aei231. Epub 2005 Sep 2.
PubMed 16143575Archer GW Jr, Marx GF. Arterial oxygen tension during apnoea in parturient women. Br J Anaesth. 1974 May;46(5):358-60. doi: 10.1093/bja/46.5.358. No abstract available.
PubMed 4157184McClelland SH, Bogod DG, Hardman JG. Apnoea in pregnancy: an investigation using physiological modelling. Anaesthesia. 2008 Mar;63(3):264-9. doi: 10.1111/j.1365-2044.2007.05347.x.
PubMed 18289232McClelland SH, Bogod DG, Hardman JG. Pre-oxygenation and apnoea in pregnancy: changes during labour and with obstetric morbidity in a computational simulation. Anaesthesia. 2009 Apr;64(4):371-7. doi: 10.1111/j.1365-2044.2008.05785.x.
PubMed 19317700Patil S, Sinha P, Krishnan S. Successful delivery in a morbidly obese patient after failed intubation and regional technique. Br J Anaesth. 2007 Dec;99(6):919-20. doi: 10.1093/bja/aem326. No abstract available.
PubMed 18006534Hawkins JL, Chang J, Palmer SK, Gibbs CP, Callaghan WM. Anesthesia-related maternal mortality in the United States: 1979-2002. Obstet Gynecol. 2011 Jan;117(1):69-74. doi: 10.1097/AOG.0b013e31820093a9.
PubMed 21173646Teller LE, Alexander CM, Frumin MJ, Gross JB. Pharyngeal insufflation of oxygen prevents arterial desaturation during apnea. Anesthesiology. 1988 Dec;69(6):980-2. doi: 10.1097/00000542-198812000-00035. No abstract available.
PubMed 3195773
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A "Less-rapid" Sequence Anesthetic Induction/Intubation Sequence? Does Apneic Oxygenation by Means of an Oxygenating Laryngoscope Blade Prolong the "Duration of Apnea Without Desaturation" in Paralyzed Non-obese and Morbidly Obese Patients?
- ClinicalTrials.gov ID
- NCT02943629
- Acronym / sponsor ID
- 160579
- Conditions
- Apneic Oxygenation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 25 Oct 2016 (estimated)
- 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 study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade (Figure 1) as the means to provide Apneic Oxygenation (AO) and prolong Duration of Apnea Without Desaturation (DAWD) in non-obese and morbidly obese females.
Detailed description
Pre-oxygenation/de-nitrogenation for three minutes of spontaneous breathing or alternatively four to eight deep breaths prior to rapid sequence anesthetic induction/intubation (RSII) in patients with healthy lungs, low oxygen demands and normal hemoglobin levels allows up to eight minutes of safe apnea time or DAWD.
The study will test the efficacy of the Pentax AWSTM video laryngoscope (VLS) equipped with a P Blade as the means to provide apneic oxygenation and prolong DAWD. The P Blade sports a suction conduit which can equally well provide a conduit for oxygen administration. The initial phase of the study will include non-obese healthy (ASAR 1-2) women patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery. Subsequently a cohort of morbidly obese patients (BM I ≥ 40 kg/m2) also requiring gynecologic abdominal access will be recruited for investigation.
Participants of each group (obese, non-obese) will be randomized to apneic oxygenation with the the Pentax AWS Laryngoscope or no apneic oxygenation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Obese: Apneic Oxygenation: eight minute | Experimental | Device: Apneic oxygenation: Eight minuteNon-obese healthy female patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed and then receive 10 l/minute flow of oxygen through the P blade (apneic oxygenation) for eight minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. |
| Non-Obese: Without Apneic Oxygenation | Other | Device: Without apneic oxygenationNon-obese healthy female patients requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed for eight minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. |
| Obese: Apneic Oxygenation: five minute | Experimental | Device: Apneic oxygenation: five minutesMorbidly obese patients (BM I ≥ 40 kg/m2) requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed and then receive 10 l/minute flow of oxygen through the P blade (apneic oxygenation) for five minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. |
| Obese: Without Apneic Oxygenation | Other | Device: Without apneic oxygenationMorbidly obese patients (BM I ≥ 40 kg/m2) requiring endotracheal anesthesia for gynecologic (open or laparoscopic) abdominal surgery will have the Pentax AWSTM video laryngoscope with attached P blade placed for five minutes, or earlier if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients,
- American Society of Anesthesiologists Rating 1-2,
- Aged 18 through 65 years of age
- Elective gynecological surgery via an abdominal approach (laparoscopic or open)
- Already consented to general anesthesia necessitating endotracheal intubation.
Key exclusion criteria (12 listed)
- Patient refusal to enter study
- History of difficult mask ventilation
- History of, or anticipated difficult intubation
- Heavy Smokers (> 10 cigarettes per day)
- Asthma
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 |
|---|---|---|
| Apneic oxygenation: Eight minuteA Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for eight minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. | Device | Non-Obese: Apneic Oxygenation: eight minute |
| Without apneic oxygenationA Pentax AWSTM video laryngoscope with attached P blade will be placed for eight minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. | Device | Non-Obese: Without Apneic Oxygenation, Obese: Without Apneic Oxygenation |
| Apneic oxygenation: five minutesA Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for five minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%. | Device | Obese: Apneic Oxygenation: five minute |
Primary outcome
Duration of apnea without desaturation
Time frame: Time in seconds from the initiation of laryngoscopy until the time at which Sp02 falls to 95%, or until 8 minutes have elapsed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Background: PubMed 13825447FRUMIN MJ, EPSTEIN RM, COHEN G. Apneic oxygenation in man. Anesthesiology. 1959 Nov-Dec;20:789-98. doi: 10.1097/00000542-195911000-00007. No abstract available.
- Background: PubMed 23233395Paolini JB, Donati F, Drolet P. Review article: video-laryngoscopy: another tool for difficult intubation or a new paradigm in airway management? Can J Anaesth. 2013 Feb;60(2):184-91. doi: 10.1007/s12630-012-9859-5. Epub 2012 Dec 12.
- Background: PubMed 19399574Tanoubi I, Drolet P, Donati F. Optimizing preoxygenation in adults. Can J Anaesth. 2009 Jun;56(6):449-66. doi: 10.1007/s12630-009-9084-z. Epub 2009 Apr 28.
- Background: PubMed 1984382Jense 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.
- Background: PubMed 26545146Shah U, Wong J, Wong DT, Chung F. Preoxygenation and intraoperative ventilation strategies in obese patients: a comprehensive review. Curr Opin Anaesthesiol. 2016 Feb;29(1):109-18. doi: 10.1097/ACO.0000000000000267.
- Background: PubMed 22050948Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3.
- Background: PubMed 25431308De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.
- Background: PubMed 25548602Gebremedhn EG, Mesele D, Aemero D, Alemu E. The incidence of oxygen desaturation during rapid sequence induction and intubation. World J Emerg Med. 2014;5(4):279-85. doi: 10.5847/wjem.j.issn.1920-8642.2014.04.007.
- Background: PubMed 16143575Altermatt FR, Munoz HR, Delfino AE, Cortinez LI. Pre-oxygenation in the obese patient: effects of position on tolerance to apnoea. Br J Anaesth. 2005 Nov;95(5):706-9. doi: 10.1093/bja/aei231. Epub 2005 Sep 2.
- Background: PubMed 4157184Archer GW Jr, Marx GF. Arterial oxygen tension during apnoea in parturient women. Br J Anaesth. 1974 May;46(5):358-60. doi: 10.1093/bja/46.5.358. No abstract available.
- Background: PubMed 18289232McClelland SH, Bogod DG, Hardman JG. Apnoea in pregnancy: an investigation using physiological modelling. Anaesthesia. 2008 Mar;63(3):264-9. doi: 10.1111/j.1365-2044.2007.05347.x.
- Background: PubMed 19317700McClelland SH, Bogod DG, Hardman JG. Pre-oxygenation and apnoea in pregnancy: changes during labour and with obstetric morbidity in a computational simulation. Anaesthesia. 2009 Apr;64(4):371-7. doi: 10.1111/j.1365-2044.2008.05785.x.
- Individual participant dataSharing planned: No
Related trials for Apneic Oxygenation
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Oxygen Reserve Index (ORi) in Identifying Desaturation
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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.
Curtis Baysinger, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Apneic oxygenation: Eight minute, Without apneic oxygenation and Apneic oxygenation: five minutes in people with Apneic Oxygenation, run by Vanderbilt University.
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 6 inclusion and 12 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 8 May 2019. 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?
Duration of apnea without desaturation (time frame: Time in seconds from the initiation of laryngoscopy until the time at which Sp02 falls to 95%, or until 8 minutes have elapsed). 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 NCT02943629, which also lists 28 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 8 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.