NCT03529461

Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Bristol Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Non-invasive positive pressure ventilation through nasal mask	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	Rescue non-invasive positive pressure ventilation through nasal mask	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
OTHER	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 \> 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

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-04-18
• Completion: 2018-04-18
• First posted: 2018-05-18
• Last updated: 2019-05-31
• Results posted: 2019-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study