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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Severe Obesity, Hypoxia

Intervention / Treatment
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* Device: Non-invasive positive pressure ventilation through nasal mask
* Device: Rescue non-invasive positive pressure ventilation through nasal mask
* Other: Secondary rescue maneuvers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight loss surgery patients undergoing preoperative upper endoscopy BMI 40-60 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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<br>* 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<br>Other: Secondary rescue maneuvers<br>* 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<br>|
| Experimental: Experimental<br>Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated) | Device: Non-invasive positive pressure ventilation through nasal mask<br>* 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<br>Other: Secondary rescue maneuvers<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an Oxygen Desaturation Event ≤ 94% | Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94% | 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 in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 minutes following a desaturation event < 90 % | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, severe obesity, non-invasive positive pressure ventilation, endoscopy, hypoxia, bariatric surgery, sedation, adverse events, anesthesia, complications