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

B

Bristol Hospital

Status

Completed

Conditions

Hypoxia
Severe Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03529461
20170730

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

56 participants in 2 patient groups

Control
Other group
Description:
Intervention: nasal cannula (6L O2) + non invasive positive pressure nasal mask (not connected to machine)
Treatment:
Device: Rescue non-invasive positive pressure ventilation through nasal mask
Other: Secondary rescue maneuvers
Experimental
Experimental group
Description:
Intervention: Non invasive positive pressure nasal mask (connect to machine once patient is sedated)
Treatment:
Device: Non-invasive positive pressure ventilation through nasal mask
Other: Secondary rescue maneuvers

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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