High Flow Nasal Cannula in Patients Undergoing Colonoscopy

NCT05687045 | Unknown

• 1 other identifier: Colon-HFNC
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

During colonoscopy, the insertion of the fiberscope and colon 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 colonoscopy. The investigators 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

Colonoscopy

Keywords

colonoscopy; High Flow Nasal Cannula; Gas exchange

Outcome Measures

Primary Outcomes (1)

• Arterial blood gases at end of the procedure

  Arterial blood will be sample for gas analysis

  At the end of the endoscopy

Secondary Outcomes (8)

• Respiratory effort at end of the procedure

  At the end of the endoscopy

• Respiratory effort at baseline

  At enrollment

• Respiratory effort at the beginning of the colonoscopy

  At 5 minutes after the beginning of the procedure

• Respiratory effort after the colonoscopy

  After 10 minute from the end of the endoscopy

• Change of end-expiratory lung impedance (dEELI) from baseline at the beginning of the colonoscopy

  At 5 minutes after the beginning of the procedure

Study Arms (2)

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.

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

Device: Conventional Oxygen Therapy

Interventions

High Flow Nasal Cannula 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%

High Flow Nasal Cannula

Conventional Oxygen Therapy 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%

Standard Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients with the indication to diagnostic colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

Study Officials

• Federico Longhini

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

+393475395967; longhini.federico@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Intensive Care and Anesthesia Department

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: January 17, 2023
• Study Start: February 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be shared after results publication of indexed journal in english language
• Access Criteria: On reasonable request

Locations

IT (1)