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

May 8, 2019 updated by: Makram Gedeon, MD, Bristol Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Bristol Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
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
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
Experimental: Experimental
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol Hospital

Investigators

  • Principal Investigator: Makram M Gedeon, MD, Bristol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2017

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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