Trial Outcomes & Findings for Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures (NCT NCT03529461)
NCT ID: NCT03529461
Last Updated: 2019-05-31
Results Overview
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).
Results posted on
2019-05-31
Participant Flow
Recruitment began on 4/25/2017 and ended on 4/2/2018.
208 patients assessed for eligibility: * 56 patients enrolled * 152 patients excluded (reasons: 127 not meeting inclusion criteria or no show for procedure, 6 patients declined to participate, 19 patients excluded because of early trial closure)
Participant milestones
| Measure |
Control
Intervention: nasal cannula 6L O2 + non invasive positive pressure (NIPPV) nasal mask not connected to machine
Rescue NIPPV via nasal mask: If oxygen desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 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.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted and O2 saturation 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. If oxygen saturation \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase \> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist
|
Experimental
Intervention: NIPP placed on patient. Positive pressure applied once patient is sedated
NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: If rescue NIPPV maneuver attempted (including adjustments in pressure) and O2 saturation is not above 90 % within 3 min of starting NIPPV, endoscope 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 saturation \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If saturation does not increase \> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Baseline characteristics by cohort
| Measure |
Control
n=28 Participants
Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine
Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 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.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted 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. If sat \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist
|
Experimental
n=28 Participants
Intervention: Non invasive positive pressure nasal mask connected once patient is sedated
NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: 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 \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
37.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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%
Outcome measures
| Measure |
Control
n=28 Participants
Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine
Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 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.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted 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. If sat \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist
|
Experimental
n=28 Participants
Intervention: Non invasive positive pressure nasal mask connected once patient is sedated
NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: 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 \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
|
|---|---|---|
|
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
|
57.1 percentage of participants
|
14.3 percentage of participants
|
PRIMARY outcome
Timeframe: 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%.
Outcome measures
| Measure |
Control
n=28 Participants
Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine
Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 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.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted 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. If sat \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist
|
Experimental
n=28 Participants
Intervention: Non invasive positive pressure nasal mask connected once patient is sedated
NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: 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 \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
|
|---|---|---|
|
Percentage of Participants With an Oxygen Desaturation Event < 90%
|
28.6 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: 3 minutes following a desaturation event < 90 %Population: We report on the response of 8 participants in the control group who had an oxygen desaturation event less than 90 %
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.
Outcome measures
| Measure |
Control
n=8 Participants
Intervention: nasal cannula 6L O2 + non invasive positive pressure nasal mask not connected to machine
Rescue NIPPV via nasal mask: If desaturation below 90 %. IPAP 12 cm H2O/EPAP 6 cm H2O titrated to meet a tidal volume of 300-800mL target is 450-500, with maximum IPAP 18cm H2O /EPAP 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.
Secondary rescue maneuvers: If rescue non invasive positive pressure maneuver attempted 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. If sat \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam cancelled and patient care per anesthesiologist
|
Experimental
Intervention: Non invasive positive pressure nasal mask connected once patient is sedated
NIPPV through nasal mask: IPAP 12cm H2O/EPAP 6cm H2O titrated to tidal volume of 300-800 mL (target 450-500), maximum IPAP 18 cm H2O /EPAP 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, pressure will be adjusted by 1-2 cm H2O.
Secondary rescue maneuvers: 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 \> 94 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase \> 94 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
|
|---|---|---|
|
Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
|
8 Participants
|
—
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place