MedTrace Logo

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

NCT03529461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-05-31

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Bristol Hospital

    lead OTHER

Principal Investigators

  • Makram M Gedeon, MD · Bristol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2018-04-18
Completion
2018-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529461 on ClinicalTrials.gov