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

Primary Purpose

Severe Obesity, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive positive pressure ventilation through nasal mask
Rescue non-invasive positive pressure ventilation through nasal mask
Secondary rescue maneuvers
Sponsored by
Bristol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Obesity focused on measuring severe obesity, non-invasive positive pressure ventilation, endoscopy, hypoxia, bariatric surgery, sedation, adverse events, BMI, anesthesia, complications

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Bristol Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Experimental

Arm Description

Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)

Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)

Outcomes

Primary Outcome Measures

Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%
Percentage of Participants With an Oxygen Desaturation Event < 90%
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
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.

Full Information

First Posted
May 3, 2018
Last Updated
May 8, 2019
Sponsor
Bristol Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03529461
Brief Title
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Official Title
Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bristol Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity, Hypoxia
Keywords
severe obesity, non-invasive positive pressure ventilation, endoscopy, hypoxia, bariatric surgery, sedation, adverse events, BMI, anesthesia, complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
Intervention Type
Device
Intervention Name(s)
Non-invasive positive pressure ventilation through nasal mask
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Rescue non-invasive positive pressure ventilation through nasal mask
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Secondary rescue maneuvers
Intervention Description
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 Measure Information:
Title
Percentage of Participants With an Oxygen Desaturation Event ≤ 94%
Description
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).
Title
Percentage of Participants With an Oxygen Desaturation Event < 90%
Description
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).
Secondary Outcome Measure Information:
Title
Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV
Description
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 %

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makram M Gedeon, MD
Organizational Affiliation
Bristol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Hospital
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures

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