HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU

NCT06350864 | Completed DMC FDA Device

• 1 other identifier: FMASU R11/2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) .

Conditions

Upper Gastrointestinal Bleeding

Keywords

High-flow Nasal Cannula (HFNC) Oxygen Therapy; Conventional Nasal Oxygen Therapy (COT); Upper Gastrointestinal (UGI) Endoscopy; Intensive Care Unit (ICU); Hypoxia

Outcome Measures

Primary Outcomes (1)

• Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure.

  moderate hypoxemia, defined as SpO2 \< 90%

  During the procedure.

Secondary Outcomes (6)

• The median lowest SpO2

  During the procedure

• Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes

  During the procedure

• Clinically significant hypoxia

  During the procedure

• Sedation related adverse effects (SRAEs)

  During the procedure and immediately after the procedure for 6 hours

• Procedure-related adverse events (PRAEs)

  During the procedure and immediately after the procedure for 24 hours

Other Outcomes (2)

• Endoscopy procedure time

  During the procedure

• Anesthetic time

  During the procedure

Study Arms (2)

Conventional nasal oxygen therapy (COT) group (35 patients)

ACTIVE COMPARATOR

Who will receive 5 L/min oxygen flow through standard nasal cannula (gives FiO2 of about 0.4). The allocated flow rates will be maintained throughout the procedure unless intervention will be required at the discretion of the anesthesiologist in charge of the case.

Device: Conventional nasal oxygen therapy (COT); Device: Upper gastrointestinal endoscopy (UGE) including gastroscopy; Device: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)

High-flow nasal cannula (HFNC) group (35 patients)

ACTIVE COMPARATOR

Who will receive 30 L/min oxygen flow through VapothermR Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4, temperature at 37◦C with 100% humidity.

Device: High-flow nasal cannula (HFNC); Device: Upper gastrointestinal endoscopy (UGE) including gastroscopy; Device: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)

Interventions

High-flow nasal cannula (HFNC) DEVICE

high flow cartridge and adult size nasal cannula: (flow range: 5-40L/minute, oxygen concentration (FiO2): 21-100%, temperature range: 33-39◦ C, humidity minimum of 12mg/liter)

Also known as: Vapotherm Precision Flow HI-VNI Technology device

High-flow nasal cannula (HFNC) group (35 patients)

Conventional nasal oxygen therapy (COT) DEVICE

Adult size, single use nasal cannula

Also known as: Ultramed

Conventional nasal oxygen therapy (COT) group (35 patients)

Upper gastrointestinal endoscopy (UGE) including gastroscopy DEVICE

Upper gastrointestinal endoscopy (UGE) will be either diagnostic and/or therapeutic including variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation.

Also known as: Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).

Conventional nasal oxygen therapy (COT) group (35 patients); High-flow nasal cannula (HFNC) group (35 patients)

Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) DEVICE

Upper gastrointestinal endoscopy (UGE) will be diagnostic

Also known as: Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).

Conventional nasal oxygen therapy (COT) group (35 patients); High-flow nasal cannula (HFNC) group (35 patients)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both males and females with age 20-60 years
• American Society of Anesthesiologists (ASA) class I, II or III
• Patients will undergo UGI endoscopic procedure with anticipated procedure time of over 15 minutes because of complexity of the procedure or recurrence, as assessed by the consultant gastroenterologist responsible for the case

You may not qualify if:

• Patient refusal or propofol allergy history.
• Suspected difficult airway or Mallampati score more than 3
• Body mass index (BMI) more than 35 kg/m2 (weight will be measured in kilograms and height in meters,then BMI will be measured by equation where: BMI=weight(Kg) / height square (m2))
• Pregnant patients
• Respiratory compromise as patients dependent on supplemental oxygen including respiratory failure or with active chest condition e.g. bronchial asthma or pneumonia
• Cardiovascular compromise including heart failure and shocked patients
• Severe uncontrolled hematemesis with shocked or risk of aspiration.
• Patients deemed as high risk of SRAEs by the anesthesiologist, anticipated requirement or plan for general anesthesia involving airway instrumentation including a laryngeal mask or tracheal intubation.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University-Faculty of Medicine

Cairo, Egypt

Location

Related Publications (1)

• Mohamed AM, Selima WZ. HFNC Oxygen Therapy vs COT in Prolonged Upper Gastrointestinal Endoscopy Inside the ICU: A Prospective, Randomized, Controlled Clinical Study. Indian J Crit Care Med. 2025 Mar;29(3):223-229. doi: 10.5005/jp-journals-10071-24919. Epub 2025 Feb 28.

  PMID: 40110237 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hypoxia

Interventions

Endoscopy, Digestive System; Endosonography

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Ultrasonography; Diagnostic Imaging

Study Officials

• Ahmed M Mohamed, MD

  Ain Shames University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The patients and anesthesiologists in charge of the case will be unmasked as High-flow nasal cannula HFNC) shape,setting and preparation are completely different from the Conventional nasal oxygen therapy (COT), so masking both of them is impossible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, comparative, controlled clinical trial study

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: April 5, 2024
• Study Start: April 10, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 20, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)