Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
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| ClinicalTrials.gov Identifier: NCT03529461 |
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Recruitment Status :
Completed
First Posted : May 18, 2018
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
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Sponsor:
Bristol Hospital
Information provided by (Responsible Party):
Makram Gedeon, MD, Bristol Hospital
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Severe Obesity Hypoxia | Device: Non-invasive positive pressure ventilation through nasal mask Device: Rescue non-invasive positive pressure ventilation through nasal mask Other: Secondary rescue maneuvers | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 56 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | Randomized controlled trial |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures |
| Actual Study Start Date : | April 25, 2017 |
| Actual Primary Completion Date : | April 18, 2018 |
| Actual Study Completion Date : | April 18, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Control
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
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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 |
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Experimental: Experimental
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
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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 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 |
Primary Outcome Measures :
- 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%.
Secondary Outcome Measures :
- 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 % ]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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529461
Locations
| United States, Connecticut | |
| Bristol Hospital | |
| Bristol, Connecticut, United States, 06010 | |
Sponsors and Collaborators
Bristol Hospital
Investigators
| Principal Investigator: | Makram M Gedeon, MD | Bristol Hospital |
Study Documents (Full-Text)
Documents provided by Makram Gedeon, MD, Bristol Hospital:
Documents provided by Makram Gedeon, MD, Bristol Hospital:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form [PDF] April 23, 2019
Publications:
| Responsible Party: | Makram Gedeon, MD, Medical director of bariatric surgery program, principal investigator, Bristol Hospital |
| ClinicalTrials.gov Identifier: | NCT03529461 |
| Other Study ID Numbers: |
20170730 |
| First Posted: | May 18, 2018 Key Record Dates |
| Results First Posted: | May 31, 2019 |
| Last Update Posted: | May 31, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Makram Gedeon, MD, Bristol Hospital:
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severe obesity non-invasive positive pressure ventilation endoscopy hypoxia bariatric surgery |
sedation adverse events BMI anesthesia complications |
Additional relevant MeSH terms:
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Obesity Obesity, Morbid Hypoxia Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms, Respiratory |