Severe ObesityNCT03529461
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
A study testing Non-invasive positive pressure ventilation through nasal mask, Rescue non-invasive positive pressure ventilation through nasal mask and Secondary rescue maneuvers in people with Severe Obesity and Hypoxia, run by Bristol Hospital at 1 site in United States.
Trial summary
The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Obesity, Hypoxia
- What is being tested?
- Non-invasive positive pressure ventilation through nasal mask, Rescue non-invasive positive pressure ventilation through nasal mask and Secondary rescue maneuvers
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 18 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight loss surgery patients undergoing preoperative upper endoscopy
- BMI 40-60
Who cannot join
- Pregnant patients
- Previous weight loss surgery or stomach surgery
- BMI > 60 and BMI < 40
- Active smokers
- Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks
- Lung disease, COPD asthma, cystic fibrosis, sarcoidosis
- Baseline O2 saturation less than or equal to 94%
- Exclude substance abusers (active alcohol abuse, benzodiazepine abuse, and active illicit drug use)
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.
Read the detailed description
Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 <=94%) and desaturation events requiring intervention (SpO2<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.
- Conditions
- Severe Obesity, Hypoxia
- Being tested
- Non-invasive positive pressure ventilation through nasal mask, Rescue non-invasive positive pressure ventilation through nasal mask, Secondary rescue maneuvers
- Keywords
- severe obesity, non-invasive positive pressure ventilation, endoscopy, hypoxia, bariatric surgery, sedation, adverse events, BMI, anesthesia, complications
- Medical subject headings
- Obesity, Morbid, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive positive pressure ventilation through nasal maskDevice
Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
Rescue non-invasive positive pressure ventilation through nasal maskDevice
If desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
Secondary rescue maneuversOther
If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat > 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine) Receives: Device: Rescue non-invasive positive pressure ventilation through nasal mask; Other: Secondary rescue maneuvers |
| Experimental | Experimental | Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated) Receives: Device: Non-invasive positive pressure ventilation through nasal mask; Other: Secondary rescue maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Measured: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Percentage of Participants With an Oxygen Desaturation Event < 90%
Percentage of participants who develop a peripheral oxygen saturation event < 90%.
Measured: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Secondary outcomes (1)
Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes.
Measured: 3 minutes following a desaturation event < 90 %
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start25 Apr 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Severe ObesityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makram Gedeon, MD, Bristol Hospital
- Investigators
- Makram M Gedeon, MD, Principal investigator, Bristol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529461
- Sponsor's protocol ID
- 20170730
- Status last verified
- May 2019
- First submitted
- 3 May 2018
- Last updated
- 31 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.
PubMed 16645462Arakawa H, Kaise M, Sumiyama K, Saito S, Suzuki T, Tajiri H. Does pulse oximetry accurately monitor a patient's ventilation during sedated endoscopy under oxygen supplementation? Singapore Med J. 2013 Apr;54(4):212-5. doi: 10.11622/smedj.2013075.
PubMed 23624448De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.
PubMed 24976715Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
PubMed 27272580Fouladpour N, Jesudoss R, Bolden N, Shaman Z, Auckley D. Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Anesth Analg. 2016 Jan;122(1):145-51. doi: 10.1213/ANE.0000000000000841.
PubMed 26111263Gay PC. Complications of noninvasive ventilation in acute care. Respir Care. 2009 Feb;54(2):246-57; discussion 257-8.
PubMed 19173756Gomez V, Bhalla R, Heckman MG, Florit PT, Diehl NN, Rawal B, Lynch SA, Loeb DS. Routine Screening Endoscopy before Bariatric Surgery: Is It Necessary? Bariatr Surg Pract Patient Care. 2014 Dec 1;9(4):143-149. doi: 10.1089/bari.2014.0024.
PubMed 25516819Goudra BG, Singh PM, Penugonda LC, Speck RM, Sinha AC. Significantly reduced hypoxemic events in morbidly obese patients undergoing gastrointestinal endoscopy: Predictors and practice effect. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):71-7. doi: 10.4103/0970-9185.125707.
PubMed 24574597McVay T, Fang JC, Taylor L, Au A, Williams W, Presson AP, Al-Dulaimi R, Volckmann E, Ibele A. Safety Analysis of Bariatric Patients Undergoing Outpatient Upper Endoscopy with Non-Anesthesia Administered Propofol Sedation. Obes Surg. 2017 Jun;27(6):1501-1507. doi: 10.1007/s11695-016-2478-4.
PubMed 27885537Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.
PubMed 27101493Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016 Mar;4(3):E340-51. doi: 10.1055/s-0042-100719.
PubMed 27004254Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.
PubMed 23992025Soto RG, Davis M, Faulkner MJ. A comparison of the incidence of hypercapnea in non-obese and morbidly obese peri-operative patients using the SenTec transcutaneous pCO(2) monitor. J Clin Monit Comput. 2014 Jun;28(3):293-8. doi: 10.1007/s10877-013-9534-6. Epub 2013 Nov 29.
PubMed 24292821Wani S, Azar R, Hovis CE, Hovis RM, Cote GA, Hall M, Waldbaum L, Kushnir V, Early D, Mullady DK, Murad F, Edmundowicz SA, Jonnalagadda SS. Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures. Gastrointest Endosc. 2011 Dec;74(6):1238-47. doi: 10.1016/j.gie.2011.09.006.
PubMed 22136773
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
- ClinicalTrials.gov ID
- NCT03529461
- Acronym / sponsor ID
- 20170730
- Conditions
- Severe Obesity, Hypoxia
- Keywords
- severe obesity, non-invasive positive pressure ventilation, endoscopy, hypoxia, bariatric surgery, sedation, adverse events, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bristol HospitalUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 31 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.
Detailed description
Patients being evaluated for bariatric surgery often undergo preoperative upper endoscopy. Patients with obesity are at increased risk for sedation related adverse events during endoscopy. The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation in patients with severe obesity undergoing upper endoscopy. The study was a randomized controlled trial that assessed the effectiveness of NIPPV in patients undergoing upper endoscopy. Patients were randomized into experimental group NIPPV or control group. Primary endpoints were desaturation events (SpO2 <=94%) and desaturation events requiring intervention (SpO2<=90%). A secondary endpoint was the use of NIPPV to rescue patients who developed a clinically significant desaturation event.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: Rescue non-invasive positive pressure ventilation through nasal mask, Other: Secondary rescue maneuversIntervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine) |
| Experimental | Experimental | Device: Non-invasive positive pressure ventilation through nasal mask, Other: Secondary rescue maneuversIntervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Weight loss surgery patients undergoing preoperative upper endoscopy
- BMI 40-60
Key exclusion criteria (8 listed)
- Pregnant patients
- Previous weight loss surgery or stomach surgery
- BMI > 60 and BMI < 40
- Active smokers
- Patients with a history of recent URTI (Upper Respiratory Tract Infection) within the preceding 2 weeks
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 |
|---|---|---|
| Non-invasive positive pressure ventilation through nasal maskInspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly | Device | Experimental |
| Rescue non-invasive positive pressure ventilation through nasal maskIf desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly | Device | Control |
| Secondary rescue maneuversIf rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat > 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist | Other | Control, Experimental |
Primary outcome
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Time frame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Percentage of Participants With an Oxygen Desaturation Event < 90%
Time frame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Percentage of participants who develop a peripheral oxygen saturation event < 90%.
1 secondary outcome
Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
Time frame: 3 minutes following a desaturation event < 90 %
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16645462Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.
- Background: PubMed 23624448Arakawa H, Kaise M, Sumiyama K, Saito S, Suzuki T, Tajiri H. Does pulse oximetry accurately monitor a patient's ventilation during sedated endoscopy under oxygen supplementation? Singapore Med J. 2013 Apr;54(4):212-5. doi: 10.11622/smedj.2013075.
- Background: PubMed 24976715De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.
- Background: PubMed 27272580Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
- Background: PubMed 26111263Fouladpour N, Jesudoss R, Bolden N, Shaman Z, Auckley D. Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Anesth Analg. 2016 Jan;122(1):145-51. doi: 10.1213/ANE.0000000000000841.
- Background: PubMed 19173756Gay PC. Complications of noninvasive ventilation in acute care. Respir Care. 2009 Feb;54(2):246-57; discussion 257-8.
- Background: PubMed 25516819Gomez V, Bhalla R, Heckman MG, Florit PT, Diehl NN, Rawal B, Lynch SA, Loeb DS. Routine Screening Endoscopy before Bariatric Surgery: Is It Necessary? Bariatr Surg Pract Patient Care. 2014 Dec 1;9(4):143-149. doi: 10.1089/bari.2014.0024.
- Background: PubMed 24574597Goudra BG, Singh PM, Penugonda LC, Speck RM, Sinha AC. Significantly reduced hypoxemic events in morbidly obese patients undergoing gastrointestinal endoscopy: Predictors and practice effect. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):71-7. doi: 10.4103/0970-9185.125707.
- Background: PubMed 27885537McVay T, Fang JC, Taylor L, Au A, Williams W, Presson AP, Al-Dulaimi R, Volckmann E, Ibele A. Safety Analysis of Bariatric Patients Undergoing Outpatient Upper Endoscopy with Non-Anesthesia Administered Propofol Sedation. Obes Surg. 2017 Jun;27(6):1501-1507. doi: 10.1007/s11695-016-2478-4.
- Background: PubMed 27101493Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.
- Background: PubMed 27004254Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016 Mar;4(3):E340-51. doi: 10.1055/s-0042-100719.
- Background: PubMed 23992025Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.
- Individual participant dataSharing planned: No
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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.
Makram M Gedeon, MD principal investigator
Bristol 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 Non-invasive positive pressure ventilation through nasal mask, Rescue non-invasive positive pressure ventilation through nasal mask and Secondary rescue maneuvers in people with Severe Obesity and Hypoxia, run by Bristol Hospital at 1 site in United States.
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 2 inclusion and 8 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 31 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With an Oxygen Desaturation Event ≤ 94% (time frame: Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).). The study lists 2 primary outcomes in all. 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 NCT03529461, which also lists 14 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 31 May 2019.