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.
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.
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:
- All patients will be subjected to full history taking and thorough physical examination.
- Age, sex and American Society Association (ASA) physical status were recorded.
- Preoperative investigations will be done to all patients including laboratory investigations.
- Oxygen saturation (SpO2) is recorded in ambient air
- preoperative monitoring including ECG, non-invasive blood pressure and SpO2 via pulse oximeter are displayed and recorded in each patient using standard anaesthesia monitors.
- 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.
- Conditions
- Prevention of Intraoperative Hypoxia
- 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 group | Role | What they receive |
|---|---|---|
| High flow nasal cannula group | Active comparator | Not described Receives: Device: High flow nasal cannula (HFNO) |
| Nasal cannula group | Active comparator | Not described Receives: Device: nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence of hypoxia
SpO2 <90%
Measured: during the procedure
Secondary outcomes (6)
occurence of hypoxia
SpO2 ≤92%
Measured: from recovery room admission till discharge up to one hour
The rate of modifications of oxygen flow in both groups and of the FiO2 in the HFNO group.
Measured: during the procedure
number of participants needed to use mask ventilation or to perform any airway intervention
Measured: during the procedure
number of participants needed non- invasive ventilation, laryngeal mask airway or for intubation
Measured: during the procedure
number of participants needed to stop the procedure
Measured: during the procedure
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.
- First posted30 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Intraoperative HypoxiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Oxygenation Versus Standard Oxygenation for Gastrointestinal Endoscopy With Sedation in Obese Patients
- ClinicalTrials.gov ID
- NCT06231836
- Acronym / sponsor ID
- FMASU Master 763/2023
- Conditions
- Prevention of Intraoperative Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Pre-operative settings:
- All patients will be subjected to full history taking and thorough physical examination.
- Age, sex and American Society Association (ASA) physical status were recorded.
- Preoperative investigations will be done to all patients including laboratory investigations.
- Oxygen saturation (SpO2) is recorded in ambient air
- preoperative monitoring including ECG, non-invasive blood pressure and SpO2 via pulse oximeter are displayed and recorded in each patient using standard anaesthesia monitors.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula group | Active comparator | Device: High flow nasal cannula (HFNO) |
| Nasal cannula group | Active comparator | Device: nasal cannula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Gastrointestinal endoscopy (GIE) performed in emergency.
- Necessity to intubate the patient for the procedure.
- Patient under oxygen therapy at home.
- Tracheostomised patient.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow nasal cannula (HFNO)O2 is administered by HFNO with flow 70L/min and the FiO2 is set at 40%, | Device | High flow nasal cannula group |
| nasal cannulaO2 is administered by nasal cannula at 6L/min | Device | Nasal cannula group |
Primary outcome
occurence of hypoxia
Time frame: during the procedure
SpO2 <90%
6 secondary outcomes
occurence of hypoxia
Time frame: from recovery room admission till discharge up to one hour
The rate of modifications of oxygen flow in both groups and of the FiO2 in the HFNO group.
Time frame: during the procedure
number of participants needed to use mask ventilation or to perform any airway intervention
Time frame: during the procedure
number of participants needed non- invasive ventilation, laryngeal mask airway or for intubation
Time frame: during the procedure
number of participants needed to stop the procedure
Time frame: during the procedure
occurence of hypercapnia (end tidal carbon dioxide >40 millimeter mercury)
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.