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Prevention of Intraoperative HypoxiaNCT06231836

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

A study testing High flow nasal cannula (HFNO) and nasal cannula in people with Prevention of Intraoperative Hypoxia, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prevention of Intraoperative Hypoxia
What is being tested?
High flow nasal cannula (HFNO) and nasal cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
20 Jan 2024to 20 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams university

    Cairo, 20

Other trials in Egypt

About this study

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.
Being tested
High flow nasal cannula (HFNO), nasal cannula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High flow nasal cannula (HFNO)Device

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

  • nasal cannulaDevice

    O2 is administered by nasal cannula at 6L/min

Study groups in NCT06231836
Study groupRoleWhat they receive
High flow nasal cannula groupActive comparatorNot described
Receives: Device: High flow nasal cannula (HFNO)
Nasal cannula groupActive comparatorNot described
Receives: Device: nasal cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurence of hypoxia

    SpO2 <90%

    Measured: during the procedure

Secondary outcomes (6)
  1. occurence of hypoxia

    SpO2 ≤92%

    Measured: 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.

    Measured: during the procedure

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

    Measured: during the procedure

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

    Measured: during the procedure

  5. number of participants needed to stop the procedure

    Measured: during the procedure

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

    Measured: during the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start20 Jan 2024 (estimated)
  3. Primary completion20 Jul 2024 (estimated)
  4. Study completion20 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231836
Sponsor's protocol ID
FMASU Master 763/2023
Status last verified
Jan 2024
First submitted
8 Jan 2024
Last updated
30 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High flow nasal cannula (HFNO) and nasal cannula in people with Prevention of Intraoperative Hypoxia, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurence of hypoxia (time frame: during the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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