GastroscopyNCT05693298
High Flow Nasal Cannula in Patients Undergoing Gastroscopy
A study testing High Flow Nasal Cannula and Conventional Oxygen Therapy in people with Gastroscopy, run by University Magna Graecia at 1 site in Italy.
Trial summary
During gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce modifications to respiratory mechanics, respiratory effort and breathing pattern. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Gastroscopy
- What is being tested?
- High Flow Nasal Cannula and Conventional Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 30 Jun 2023
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- outpatients with the indication to diagnostic gastroscopy
Who cannot join
- life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
- need for invasive or non invasive ventilation
- presence of pneumothorax or pulmonary enphisema or bullae
- recent (within 1 week) thoracic surgery
- presence of chest burns
- presence of tracheostomy
Show all 10Show fewer
- pregnancy
- nasal or nasopharyngeal diseases
- dementia
- lack of consent or its withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Gastroscopy: a Randomized Controlled Trial.
During gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce modifications to respiratory mechanics, respiratory effort and breathing pattern.
High-flow nasal cannula (HFNC) therapy is a mixed air-oxygen supply system able to deliver heated humidified gas up to 60 L/min of flow rate, with an inspiratory oxygen fraction (FiO2) ranging from 21% to 100%. Increasing evidence supports the use of HFNC in several clinical conditions and settings. When compared to standard therapy (ST), HFNC results in enhanced gas exchange and improved comfort.
No studies have yet assessed the benefits of HFNC versus ST during and after gastroscopy. We designed this unblinded randomized controlled trial to assess whether HFNC, compared to ST, improves oxygenation at the end of the procedure (primary endpoint). Additional endpoints were: 1) the lowest peripheral saturation of oxygen (SpO2) and the number of oxygen desaturations; 2) the changes of end-expiratory lung impedance and tidal impedance assessed by Electrical Impedance Tomography (EIT); 3) the effects on diaphragm function assessed by ultrasound (DUS).
- Conditions
- Gastroscopy
- Being tested
- High Flow Nasal Cannula, Conventional Oxygen Therapy
- Keywords
- Gastroscopy, High Flow Nasal Cannula, Gas exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Nasal CannulaDevice
High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
Conventional Oxygen TherapyDevice
Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
| Study group | Role | What they receive |
|---|---|---|
| High Flow Nasal Cannula | Experimental | High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min. Receives: Device: High Flow Nasal Cannula |
| Standard Treatment | Active comparator | If peripheral oxygen saturation will be < 95%, conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute Receives: Device: Conventional Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gases at end of the procedure
Arterial blood will be sample for gas analysis
Measured: Through study completion, an average of 15 minutes
Secondary outcomes (8)
Respiratory effort at end of the procedure
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: Through study completion, an average of 15 minutes
Respiratory effort at baseline
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: After 1 minute from study beginning
Respiratory effort at the beginning of the gastroscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Respiratory effort after the gastroscopy
The respiratory effort will be assessed through the ultrasonographic assessment of the diaphragm thickening fraction
Measured: After 10 minute from the end of the endoscopy
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the gastroscopy
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: 5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: Through study completion, an average of 15 minutes
Change of end-expiratory lung impedance (dEELI) from baseline after gastroscopy
change from baseline, expressed in mL, of the end expiratory lung volume as assessed through electrical impedance tomography
Measured: After 10 minute from the end of the endoscopy, compared to baseline
Arterial blood gases at baseline
Arterial blood will be sample for gas analysis
Measured: After 1 minute from study beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroscopyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693298
- Sponsor's protocol ID
- EGDS HFNC
- Status last verified
- Jan 2023
- First submitted
- 14 Nov 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Therapy for Outpatients Undergoing Gastroscopy: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05693298
- Acronym / sponsor ID
- EGDS HFNC
- Conditions
- Gastroscopy
- Keywords
- Gastroscopy, High Flow Nasal Cannula, Gas exchange
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 20 Jan 2023 (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.
During gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce modifications to respiratory mechanics, respiratory effort and breathing pattern.
High-flow nasal cannula (HFNC) therapy is a mixed air-oxygen supply system able to deliver heated humidified gas up to 60 L/min of flow rate, with an inspiratory oxygen fraction (FiO2) ranging from 21% to 100%. Increasing evidence supports the use of HFNC in several clinical conditions and settings. When compared to standard therapy (ST), HFNC results in enhanced gas exchange and improved comfort.
No studies have yet assessed the benefits of HFNC versus ST during and after gastroscopy. We designed this unblinded randomized controlled trial to assess whether HFNC, compared to ST, improves oxygenation at the end of the procedure (primary endpoint). Additional endpoints were: 1) the lowest peripheral saturation of oxygen (SpO2) and the number of oxygen desaturations; 2) the changes of end-expiratory lung impedance and tidal impedance assessed by Electrical Impedance Tomography (EIT); 3) the effects on diaphragm function assessed by ultrasound (DUS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Nasal Cannula | Experimental | Device: High Flow Nasal CannulaHigh Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min. |
| Standard Treatment | Active comparator | Device: Conventional Oxygen TherapyIf peripheral oxygen saturation will be < 95%, conventional oxygen therapy will be administered through common nasal cannula with a flow up to 6 Liters per minute |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients with the indication to diagnostic gastroscopy
Key exclusion criteria (10 listed)
- life-threatening cardiac aritmia or acute miocardical infarction within 6 weeks
- need for invasive or non invasive ventilation
- presence of pneumothorax or pulmonary enphisema or bullae
- recent (within 1 week) thoracic surgery
- presence of chest burns
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 CannulaHigh Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94% | Device | High Flow Nasal Cannula |
| Conventional Oxygen TherapyConventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94% | Device | Standard Treatment |
Primary outcome
Arterial blood gases at end of the procedure
Time frame: Through study completion, an average of 15 minutes
Arterial blood will be sample for gas analysis
8 secondary outcomes
Respiratory effort at end of the procedure
Time frame: Through study completion, an average of 15 minutes
Respiratory effort at baseline
Time frame: After 1 minute from study beginning
Respiratory effort at the beginning of the gastroscopy
Time frame: 5 minutes before the beginning of the bronchial endoscopy, while receiving the assigned treatment
Respiratory effort after the gastroscopy
Time frame: After 10 minute from the end of the endoscopy
Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the gastroscopy
Time frame: 5 minutes before the beginning of the endoscopy, while receiving the assigned treatment, compared to baseline
Change of end-expiratory lung impedance (dEELI) from baseline at end of the procedure
Time frame: Through study completion, an average of 15 minutes
Change of end-expiratory lung impedance (dEELI) from baseline after gastroscopy
Time frame: After 10 minute from the end of the endoscopy, compared to baseline
Arterial blood gases at baseline
Time frame: After 1 minute from study beginning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Yes. The full protocol, datasets used and analysed during the current study will be available on reasonable request e-mailing the corresponding author
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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.
Federico Longhini, MD principal investigator
Magna Graecia University
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 and Conventional Oxygen Therapy in people with Gastroscopy, run by University Magna Graecia at 1 site in Italy.
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 1 inclusion and 10 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 20 Jan 2023. 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 Italy. 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?
Contact Federico Longhini (+393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gases at end of the procedure (time frame: Through study completion, an average of 15 minutes). 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 20 Jan 2023.