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

June 2, 2021 updated by: Mennat Allah Mahmoud Bakri, Assiut University

High Flow Nasal Oxygen Versus Nasal Continuous Positive Airway Pressure in Obese Patients Undergoing Deep Sedation for Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of hypoxia during ERCP with sedation has been reported to range from 16.2 to 39.2% (4) may be because ERCP procedures can be lengthy and are often performed in the prone position.(5) Hypoxemia is the most common adverse cardiopulmonary complication during sedated endoscopy and is caused by respiratory depression, airway obstruction, and decreased chest wall compliance. (2)

Obese patients are particularly at risk of upper airway obstruction and hypoxemia under sedation and may benefit from Conventional CPAP, applied nasally to improve ventilation and oxygenation during spontaneous ventilation in patients under deep sedation through maintenance of upper airway patency.(6) Recently novel techniques have been shown to be more effectively help ventilation than conventional low flow nasal oxygen. High flow nasal oxygen (HFNO) has been utilized in the intensive care setting for over 15 years. Its use in anaesthesia is rapidly increasing, providing an alternative to low flow oxygen devices during sedation for procedures such as gastroenterology, non-invasive cardiological, radiological, emergency medicine and persistent pain procedures.(1) Multiple mechanisms account for the therapeutic effects of HFNO, including a reduction in dead space, increased positive end-expiratory pressure, increased functional residual capacity, and delivery of higher inspired oxygen concentrations to the distal airways.(7) Moreover the heated and humidified HFNO provides adequate oxygenation with less drying of the upper airway mucosa, thereby improving patient comfort.(8) The use of HFNO in the gastroenterological suite had reduced critical incidents by providing high-inspired oxygen and slowing carbon dioxide rises related to respiratory depression.

Maintaining patient safety while successfully completing the procedures under sedation requires careful monitoring. Australian and New Zealand College of Anaesthetists (ANZCA) Guidelines on Monitoring during Anaesthesia, the Association of Anaesthetists of Great Britain & Ireland (AAGBI) and the American Society of Anesthesiologists Standards for Basic Anesthetic Monitoring had all emphasized the importance of monitoring exhaled Co2 during moderate to deep sedation to improve patients' safety. (9) Monitoring EtCO2 for the anesthesiologist is more superior to the pulse oximeter for immediately detecting an obstructed airway, opiate-induced apnea, or other airway problems that only much later may be detected by the pulse oximeter.(9) Unfortunately, it would be expected that the high oxygen flow rates during HFNO would severely dilute expired carbon dioxide and make sampling impossible.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group H
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)
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.
ACTIVE_COMPARATOR: Group M
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)
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.
ACTIVE_COMPARATOR: Group C
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A hypoxemia event
Time Frame: for 15 consecutive secondes
Spo2 <92% for at least 15 consecutive seconds (we based our definition on prior studies)
for 15 consecutive secondes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The lowest Spo2 reading
Time Frame: during the whole procedure
the lowest spo2
during the whole procedure
Incidence of hypercapnia
Time Frame: before induction, 5 min after induction and then every 10 min till end of procedure
PaCo2 will be assessed in an venous blood gas sample drawn before induction of anaesthesia and second sample 5 min. after induction and then every 10 min till the end of the procedure
before induction, 5 min after induction and then every 10 min till end of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 30, 2021

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (ACTUAL)

June 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFNO Vs CPAP in ERCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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