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NCT Number: NCT03529461

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

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.

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Key information

Conditions

Severe Obesity Body Weight Hypoxia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol Hospital

Bristol, Connecticut, 06010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-invasive positive pressure ventilation through nasal mask

Device

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

Rescue non-invasive positive pressure ventilation through nasal mask

Device

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

Secondary rescue maneuvers

Other

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 outcomes

  1. 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%

  2. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bristol Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2018
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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