HFNO Versus Nasal CPAP in Obese Patients Undergoing Deep Sedation for ERCP

NCT04912102 | Unknown

• 1 other identifier: HFNO Vs CPAP in ERCP
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed under deep sedation to provide amnesia, comfort, and optimal procedural conditions. However, anesthetic drugs commonly used such as midazolam and/or propofol and opioids for sedative endoscopy in clinical practice may depress normal ventilation by blunting central chemoreceptor responsiveness to CO2, and alveolar hypoventilation and predispose patients to upper airway obstruction; all of that can result in hypoxemia, hypercarbia, respiratory acidosis, hypotension, and, in rare cases, brain injury or death.(1-3)

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

• A hypoxemia event

  Spo2 \<92% for at least 15 consecutive seconds (we based our definition on prior studies)

  for 15 consecutive secondes

Secondary Outcomes (2)

• The lowest Spo2 reading

  during the whole procedure

• Incidence of hypercapnia

  before induction, 5 min after induction and then every 10 min till end of procedure

Study Arms (3)

Group H

ACTIVE COMPARATOR

Oxygen will be delvered via HFNO canula at 20 L/min, Fio2 0.4 and temperature of 37o c using Vapotherm Precision Flow.

Device: high flow nasal oxygen device (HFNO)

Group M

ACTIVE COMPARATOR

Mask group will be provided with nasal CPAP (10cmH2O) at an oxygen flow rate of 15 L/min.

Device: high flow nasal oxygen device (HFNO)

Group C

ACTIVE COMPARATOR

In the Control group, oxygen via a nasal cannula at a flow rate of 5 L/min will be delivered

Device: high flow nasal oxygen device (HFNO)

Interventions

high flow nasal oxygen device (HFNO) DEVICE

it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0.

Group C; Group H; Group M

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective ERCP with deep sedation will be enrolled
• age 18 - 70 years old
• obesity (BMI 30-35 kg/m2)
• American Society of Anaesthesiologists' physical status classification of 1 to 3
• Anticipated duration of the procedure is \> 15 minutes.

You may not qualify if:

• BMI \>35 kg/m2
• Simple procedures of \< 15 minutes duration.
• untreated or unstable cardiac conditions
• Nasal or oral disease resulting in difficulty of either nasal breathing or mouth breathing.
• Acute or chronic respiratory disorders as asthma and chronic obstructive pulmonary disease.
• Pregnant patients and patients having procedures with planned endotracheal intubation
• Expected difficult intubation patients.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. doi: 10.1097/00000542-200602000-00005.

  PMID: 16436839 BACKGROUND

• Amornyotin S. Sedation-related complications in gastrointestinal endoscopy. World J Gastrointest Endosc. 2013 Nov 16;5(11):527-33. doi: 10.4253/wjge.v5.i11.527.

  PMID: 24255744 BACKGROUND

• Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.

  PMID: 32398433 BACKGROUND

• Wang CY, Ling LC, Cardosa MS, Wong AK, Wong NW. Hypoxia during upper gastrointestinal endoscopy with and without sedation and the effect of pre-oxygenation on oxygen saturation. Anaesthesia. 2000 Jul;55(7):654-8. doi: 10.1046/j.1365-2044.2000.01520.x.

  PMID: 10919420 BACKGROUND

• Muller S, Prolla JC, Maguilnik I, Breyer HP. Predictive factors of oxygen desaturation of patients submitted to endoscopic retrograde cholangiopancreatography under conscious sedation. Arq Gastroenterol. 2004 Jul-Sep;41(3):162-6. doi: 10.1590/s0004-28032004000300005. Epub 2005 Jan 21.

  PMID: 15678200 BACKGROUND

• Andrade RG, Piccin VS, Nascimento JA, Viana FM, Genta PR, Lorenzi-Filho G. Impact of the type of mask on the effectiveness of and adherence to continuous positive airway pressure treatment for obstructive sleep apnea. J Bras Pneumol. 2014 Nov-Dec;40(6):658-68. doi: 10.1590/S1806-37132014000600010.

  PMID: 25610507 BACKGROUND

• Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.

  PMID: 25866645 BACKGROUND

• Greenland KB. A potential method for obtaining wave-form capnography during high flow nasal oxygen. Anaesth Intensive Care. 2019 Mar;47(2):204-206. doi: 10.1177/0310057X19836430. Epub 2019 May 1. No abstract available.

  PMID: 31042046 BACKGROUND

• Weaver J. The latest ASA mandate: CO(2) monitoring for moderate and deep sedation. Anesth Prog. 2011 Fall;58(3):111-2. doi: 10.2344/0003-3006-58.3.111. No abstract available.

  PMID: 21882985 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Menna M Bakri, assisstant lecturer

CONTACT

01090692006; mennatallah1990@aun.edu.eg

Shimaa A Hassan, lecturer

CONTACT

01002953253; shimaa.abbas@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: October 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 3, 2021

Record last verified: 2021-05