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Not yet recruitingNCT06231836Updated Jan 30, 2024

High-flow Nasal Oxygenation Versus Standard Oxygenation for Gastrointestinal Endoscopy With Sedation in Obese Patients

An interventional study of High flow nasal cannula (HFNO) and nasal cannula in Prevention of Intraoperative Hypoxia, sponsored by Ain Shams University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.

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

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Hypoxaemia is a major complication during gastrointestinal endoscopy (GIE) procedures (upper/lower) when performed under deep sedation in the procedure room especially with a body mass index above 30 kg/m².

The objective of the present work is to compare the use of High-flow nasal oxygenation (HFNO) with Standard oxygen therapy (SOT) in obese patient undergoing GIE.

Read the detailed description
  • Pre-operative settings:
  1. All patients will be subjected to full history taking and thorough physical examination.
  2. Age, sex and American Society Association (ASA) physical status were recorded.
  3. Preoperative investigations will be done to all patients including laboratory investigations.
  4. Oxygen saturation (SpO2) is recorded in ambient air
  5. preoperative monitoring including ECG, non-invasive blood pressure and SpO2 via pulse oximeter are displayed and recorded in each patient using standard anaesthesia monitors.
  6. Arterial Blood Gase(ABG) are sampled on room air .

Intraoperative settings:

  • According to ASA standard monitoring criteria (pulse oximeter, non-invasive blood pressure cuff and electrocardiogram) will be attached to all patients.
  • All patients will be monitored for peripheral oxygen saturation, blood pressure, Electrocardiogram through the whole operation.
  • Intravenous access will be applied under aseptic condition, SpO2 is recorded in ambient air.
  • Preoxygenation with the oxygen device (face mask 10L/min) for 3 min before starting the induction.
  • The induction is done by An initial bolus of propofol (0.5-1 mg/kg) is administered intravenously, followed by a repeated bolus (10-20 mg) according to the patient's condition, or a continuous propofol infusion (2-6 mg/kg/h, with an additional bolus administered as needed) The infusion rate is chosen according to the desired sedation depth and the patient risk profile .
  • In group A(intervention group) : preoxygenation for 3 min ,then start induction .Once the eyelash reflex has disappeared O2 is administered by HFNO with flow 70L/min and the FiO2 is set at 40%,The decision to set the FiO2 at 40% was made to obtain a similar FiO2 in both groups and to reduce the risk of hyperoxia and hypercapnia.
  • In group B(control group):preoxygenation for 3 min, after induction ,once the eyelash reflex has disappeared, O2 is administered by nasal cannula at 6L/min.
  • The investigator- chose to set a similar initial FiO2 in both groups during preoxygenation and procedure not to disadvantage the SOT group, as similar FiO2 will allow to determine if the HFNO- induced Positive End Expiratory Pressure PEEP and dead space washout effects could be beneficial.
  • During the procedure, in both groups, if deemed necessary, the investigator can raise the FiO2 or the gas flow in case of desaturation or for any reason.
  • In case of major intolerance, HFNO or SOT can be stopped and replaced by any other oxygen therapy technique.
  • Tracheal intubation is allowed if necessary. In every case, investigators have to record all events in the case report form.

Post-operative settings:

  • At the end of the GIE, patients are transferred to the recovery room and the interventional period is over. HFNO is not used in the recovery room. In the recovery room, SOT is immediately applied to all patients until deemed unnecessary, according to our current practice.
  • All patients are monitoring for one hour in the recovery room then transfer them to the ward and this is the end point of study.
  • ABGs are sampled in the recovery to detect the risk of hypercapnia in our study.
02

Conditions studied

  • Prevention of Intraoperative Hypoxia

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's planned enrollment of 60 is above the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia 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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Obese patient with body mass index (BMI) >30
  • Patients scheduled for GIE (upper and/or lower endoscopy), for which sedation with maintenance of spontaneous breathing is planned.
  • Patients older than 18 years old.

Exclusion criteria

Exclusion Criteria:

  • Gastrointestinal endoscopy (GIE) performed in emergency.
  • Necessity to intubate the patient for the procedure.
  • Patient under oxygen therapy at home.
  • Tracheostomised patient.
  • Pregnancy.
  • Patient not affiliated or excluded from social protection
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    High flow nasal cannula group

    Device: High flow nasal cannula (HFNO)

  • Active comparator
    Nasal cannula group

    Device: nasal cannula

Interventions

  • DeviceHigh flow nasal cannula (HFNO)

    O2 is administered by HFNO with flow 70L/min and the FiO2 is set at 40%,

  • Devicenasal cannula

    O2 is administered by nasal cannula at 6L/min

06

What researchers measure

Primary outcomes

  1. occurence of hypoxia

    SpO2 \<90%

    Time frame: during the procedure

Secondary outcomes

  1. occurence of hypoxia

    SpO2 ≤92%

    Time frame: from recovery room admission till discharge up to one hour

  2. The rate of modifications of oxygen flow in both groups and of the FiO2 in the HFNO group.

    Time frame: during the procedure

  3. number of participants needed to use mask ventilation or to perform any airway intervention

    Time frame: during the procedure

  4. number of participants needed non- invasive ventilation, laryngeal mask airway or for intubation

    Time frame: during the procedure

  5. number of participants needed to stop the procedure

    Time frame: during the procedure

  6. occurence of hypercapnia (end tidal carbon dioxide >40 millimeter mercury)

    Time frame: during the procedure

07

Study locations

1 site
  • Ain shams university
    Cairo, 20, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06231836
Lead sponsor
Ain Shams University
Responsible party
RAMY AHMED (Assistant Professor of Anesthesia, Ain Shams University) — Principal investigator
First posted
Jan 30, 2024
Start date
Jan 20, 2024 (estimated)
Primary completion
Jul 20, 2024 (estimated)
Completion
Jul 20, 2024 (estimated)
Last update
Jan 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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