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

NCT03529461 | Completed Results FDA Device

• 1 other identifier: 20170730
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Obesity; Hypoxia

Keywords

severe obesity; non-invasive positive pressure ventilation; endoscopy; hypoxia; bariatric surgery; sedation; adverse events; BMI; anesthesia; complications

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an Oxygen Desaturation Event ≤ 94%

  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%

  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 Outcomes (1)

• Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV

  3 minutes following a desaturation event < 90 %

Study Arms (2)

Control

OTHER

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; Other: Secondary rescue maneuvers

Experimental

EXPERIMENTAL

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

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

Interventions

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

Experimental

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

Control

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

Control; Experimental

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight loss surgery patients undergoing preoperative upper endoscopy
• BMI 40-60

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol Hospital: lead

Study Sites (1)

Bristol Hospital

Bristol, Connecticut, 06010, United States

Location

Related Publications (14)

• Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.

  PMID: 16645462 BACKGROUND

• Arakawa H, Kaise M, Sumiyama K, Saito S, Suzuki T, Tajiri H. Does pulse oximetry accurately monitor a patient's ventilation during sedated endoscopy under oxygen supplementation? Singapore Med J. 2013 Apr;54(4):212-5. doi: 10.11622/smedj.2013075.

  PMID: 23624448 BACKGROUND

• De Palma GD, Forestieri P. Role of endoscopy in the bariatric surgery of patients. World J Gastroenterol. 2014 Jun 28;20(24):7777-84. doi: 10.3748/wjg.v20.i24.7777.

  PMID: 24976715 BACKGROUND

• Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.

  PMID: 27272580 BACKGROUND

• Fouladpour N, Jesudoss R, Bolden N, Shaman Z, Auckley D. Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature. Anesth Analg. 2016 Jan;122(1):145-51. doi: 10.1213/ANE.0000000000000841.

  PMID: 26111263 BACKGROUND

• Gay PC. Complications of noninvasive ventilation in acute care. Respir Care. 2009 Feb;54(2):246-57; discussion 257-8.

  PMID: 19173756 BACKGROUND

• Gomez V, Bhalla R, Heckman MG, Florit PT, Diehl NN, Rawal B, Lynch SA, Loeb DS. Routine Screening Endoscopy before Bariatric Surgery: Is It Necessary? Bariatr Surg Pract Patient Care. 2014 Dec 1;9(4):143-149. doi: 10.1089/bari.2014.0024.

  PMID: 25516819 BACKGROUND

• Goudra BG, Singh PM, Penugonda LC, Speck RM, Sinha AC. Significantly reduced hypoxemic events in morbidly obese patients undergoing gastrointestinal endoscopy: Predictors and practice effect. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):71-7. doi: 10.4103/0970-9185.125707.

  PMID: 24574597 BACKGROUND

• McVay T, Fang JC, Taylor L, Au A, Williams W, Presson AP, Al-Dulaimi R, Volckmann E, Ibele A. Safety Analysis of Bariatric Patients Undergoing Outpatient Upper Endoscopy with Non-Anesthesia Administered Propofol Sedation. Obes Surg. 2017 Jun;27(6):1501-1507. doi: 10.1007/s11695-016-2478-4.

  PMID: 27885537 BACKGROUND

• Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178.

  PMID: 27101493 BACKGROUND

• Saunders R, Erslon M, Vargo J. Modeling the costs and benefits of capnography monitoring during procedural sedation for gastrointestinal endoscopy. Endosc Int Open. 2016 Mar;4(3):E340-51. doi: 10.1055/s-0042-100719.

  PMID: 27004254 BACKGROUND

• Slagelse C, Vilmann P, Hornslet P, Jorgensen HL, Horsted TI. The role of capnography in endoscopy patients undergoing nurse-administered propofol sedation: a randomized study. Scand J Gastroenterol. 2013 Oct;48(10):1222-30. doi: 10.3109/00365521.2013.830327. Epub 2013 Sep 2.

  PMID: 23992025 BACKGROUND

• Soto RG, Davis M, Faulkner MJ. A comparison of the incidence of hypercapnea in non-obese and morbidly obese peri-operative patients using the SenTec transcutaneous pCO(2) monitor. J Clin Monit Comput. 2014 Jun;28(3):293-8. doi: 10.1007/s10877-013-9534-6. Epub 2013 Nov 29.

  PMID: 24292821 BACKGROUND

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  PMID: 22136773 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Hypoxia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Makram Gedeon, MD
• Organization: Bristol Hospital

mgedeon@bristolhospital.org

8605853339

Study Officials

• Makram M Gedeon, MD

  Bristol Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director of bariatric surgery program, principal investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 18, 2018
• Study Start: April 25, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)