High Flow Nasal Cannula in Patients Undergoing Gastroscopy

NCT ID: NCT05693298

Last Updated: 2023-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Gastroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High Flow Nasal Cannula

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.

Group Type EXPERIMENTAL

High Flow Nasal Cannula

Intervention Type DEVICE

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%

Standard Treatment

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

Group Type ACTIVE_COMPARATOR

Conventional Oxygen Therapy

Intervention Type DEVICE

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%

Interventions

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High Flow Nasal Cannula

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%

Intervention Type DEVICE

Conventional Oxygen Therapy

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%

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* outpatients with the indication to diagnostic gastroscopy

Exclusion Criteria

* 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
* pregnancy
* nasal or nasopharyngeal diseases
* dementia
* lack of consent or its withdrawal
Minimum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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Federico Longhini

Director of the Intensive Care and Anesthesia Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

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AOU Mater Domini

Catanzaro, , Italy

Site Status

Countries

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Italy

Central Contacts

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Federico Longhini

Role: CONTACT

+393475395967

Other Identifiers

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EGDS HFNC

Identifier Type: -

Identifier Source: org_study_id

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