An interventional study of Non-invasive positive pressure ventilation through nasal mask and Rescue non-invasive positive pressure ventilation through nasal mask in Severe Obesity and Hypoxia, sponsored by Bristol Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-31.
Sponsored by Bristol Hospital · Not applicable, Interventional, and Supportive care
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.
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.
936 studies on the registry are indexed under Obesity, Morbid; 169 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 599 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →This is the only study on the registry with Bristol Hospital as lead sponsor.
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Exclusion Criteria:
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
Device: Rescue non-invasive positive pressure ventilation through nasal mask · Other: Secondary rescue maneuvers
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
Device: Non-invasive positive pressure ventilation through nasal mask · Other: Secondary rescue maneuvers
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
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
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
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 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 With an Oxygen Desaturation Event < 90%
Percentage of participants who develop a peripheral oxygen saturation 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 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.
Time frame: 3 minutes following a desaturation event < 90 %
Recruitment began on 4/25/2017 and ended on 4/2/2018.
| Milestone | Control | Experimental |
|---|---|---|
| Started | 28 | 28 |
| Completed | 28 | 28 |
| Not completed | 0 | 0 |
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
| percentage of participants | Control | Experimental |
|---|---|---|
| Percentage of Participants With an Oxygen Desaturation Event ≤ 94% | 57.1 | 14.3 |
Percentage of participants who develop a peripheral oxygen saturation event \< 90%.
| percentage of participants | Control | Experimental |
|---|---|---|
| Percentage of Participants With an Oxygen Desaturation Event < 90% | 28.6 | 3.5 |
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.
| Participants | Control Participants With Oxygen Desaturation < 90% |
|---|---|
| Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV | 8 |
Collected over 1800 seconds (30 minutes). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Experimental | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Age, Continuous(years) | Control | Experimental | Total |
|---|---|---|---|
| Mean | 38.8 ± 11.6 | 36.5 ± 11.8 | 37.6 ± 11.6 |
| Sex: Female, Male(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Female | 25 | 23 | 48 |
| Male | 3 | 5 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 10 | 18 |
| Not Hispanic or Latino | 20 | 18 | 38 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control | Experimental | Total |
|---|---|---|---|
| United States | 28 | 28 | 56 |
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Plan to share: No
Ran from Apr 2017 to primary completion in Apr 2018, 11 months.
Results were first posted in May 2019, 1 year 1 month after primary completion.
Of 271 non-industry interventional studies with no phase under Obesity, Morbid, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's 11 months is below that.
Counting every sponsor, half of 283 studies reached it within 26 months; a quarter within 11 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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