CompletedNCT06350864Updated Oct 29, 2024

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

An interventional study of High-flow nasal cannula (HFNC) and Conventional nasal oxygen therapy (COT) in Upper Gastrointestinal Bleeding, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

From the registry’s dates

Primary completion was Sep 2024, 2 years 1 month ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 20 Years to 60 Years
Sex: All

Study 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) .

Read the detailed description

Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt. Consented and enrolled seventy patients will be randomly assigned to one of the following two groups:

Conventional nasal oxygen therapy (COT) group (35 patients): 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.
High-flow nasal cannula (HFNC) group (35 patients): Who will receive 30 L/min oxygen flow through Vapotherm Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4,temperature at 37◦C with 100% humidity
Upper Gastrointestinal (UGI) Endoscopic and anesthetic care as following:
Pre-procedural full medical and anesthetic history, clinical examination and revision of routine investigations and radiological images will be done.
Standard monitoring via GE monitor will be connected to the patient as electrocardiogram (ECG) for heart rate (beats/min), pulse oximetry for (SpO2 as a percentage) and non invasive blood pressure (NIBP) (mmHg).
The intravenous access (IV) will be assessed and flow will be assured
After positioning the patient in the left lateral position, he will receive either HFNC or COT.
All UGI endoscopic procedures will be performed by an accredited gastroenterologist. Anesthetic care will be provided by an accredited specialist anesthesiologist. After confirming the readiness of the endoscopist, all patients will undergo deep sedation under monitored anesthetic care with the use of initial slow intravenous (IV) propofol 0.5-1mg/kg over 3-5 minutes which will be titrated to the desired clinical response.Intermittent boluses of 10-20 mg will be used as maintenance and will also be titrated to the desired sedation level. Both the endoscopist and anesthesiologist will be instructed to provide the usual care except for the participant's assigned oxygen delivery device and rate.
Interventions to change the oxygen delivery rate, Fio2 or even intubation with invasive mechanical ventilation in response to hypoxia will be at the discretion of the anesthesiologist in charge.
UGI diagnostic and therapeutic endoscopy will be performed by PentaxR Medical 90k series gastroscopy. Therapeutic gastroscopy will include 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.
Patients will continue their monitored care in the medical ICU till the control of the causes of their ICU admission or their end.
Demographics and medical conditions will be collected from the medical records and anesthesiologist assessments. Oxygenation, anesthetic and procedure-related (intraprocedural and shortly post- procedural) data will be collected also. The collected data results will be revised, electronically recorded in datasheet, coded, tabulated, analyzed, and processed using the proper computerized statistical package program. Suitable statistical analysis will be done according to the type of data obtained for each parameter with comparison between both groups to identify any significant differences between them

Conditions studied

Upper Gastrointestinal Bleeding

Browse trials for

Gastrointestinal Hemorrhage 339

Keywords

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

In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's enrollment of 70 is below the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 70 participants (actual)

Study arms

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

DeviceHigh-flow nasal cannula (HFNC)
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
DeviceConventional nasal oxygen therapy (COT)
Adult size, single use nasal cannula
Also known as: Ultramed
DeviceUpper gastrointestinal endoscopy (UGE) including gastroscopy
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).
DeviceUpper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA)
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).

What researchers measure

Primary outcomes

Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure.
moderate hypoxemia, defined as SpO2 \< 90%
Time frame: During the procedure.

Secondary outcomes

The median lowest SpO2
Measured by pulse oximetry during the procedure
Time frame: During the procedure
Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes
Hypoxemia may be: mild (SpO2 90%-94%), moderate (SpO2 76%-89%), severe (SpO2 ≤ 75%)
Time frame: During the procedure
Clinically significant hypoxia
The need to maneuver the upper airway or to change the flow, Fio2 and/or method of oxygen delivery in response to an episode of hypoxia
Time frame: During the procedure
Sedation related adverse effects (SRAEs)
They include hypotension, bradycardia, tachycardia, dysrhythmia, seizure, cardiac arrest, nausea or vomiting, recovery agitation, and delayed recovery
Time frame: During the procedure and immediately after the procedure for 6 hours
Procedure-related adverse events (PRAEs)
They include :1. Intra-procedural adverse events: The need to pause or stop the procedure because of an episode of hypoxia, gastrointestinal bleeding requiring intervention or perforation. 2. Post-procedure adverse events as abdominal pain, bloating or bleeding, throat dryness, headache,gastrointestinal bleeding requiring intervention or perforation.
Time frame: During the procedure and immediately after the procedure for 24 hours
Propofol total used doses in milligrams (mgs)
Propofol total used doses during sedation
Time frame: During the procedure

Other outcomes

Endoscopy procedure time
The duration of time the endoscope entered until exited the oral orifice.
Time frame: During the procedure
Anesthetic time
The duration of time during which intravenous sedation with propofol will be administered.
Time frame: During the procedure

Study locations

1 site

Ain Shams University-Faculty of Medicine
Cairo, Egypt

References and documents

Individual participant data

Plan to share: No — The statistics methods and results data will be shared after completing the study

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06350864
Lead sponsor: Ain Shams University
Responsible party: Sponsor
First posted: Apr 5, 2024
Start date: Apr 10, 2024
Primary completion: Sep 1, 2024
Completion: Sep 20, 2024
Last update: Oct 29, 2024

Study contacts

Ahmed M Mohamed, MD

principal investigator · Ain Shames University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Gastrointestinal Hemorrhage→

Other studies from this sponsor

Ain Shams University

Start the discussion