NCT05400642

Brief Summary

Over time, the accumulation of carbon dioxide reduces the pressure gradient for the alveolar transfer of oxygen, limiting the successful duration of apneic oxygenation. NIRS (Near-Infrared Spectroscopy) technology is able to provide an estimate of the regional balance between demand and supply of brain oxygen. The primary hypothesis of this study is that although high-flow oxygen therapy may be associated with transiently higher PaCO2 values than those found in patients undergoing tracheal intubation and traditional mechanical ventilation, due to the brevity of this phenomenon the variations in the average values of frontal cerebral tissue oxygen saturation are expected to be of similar magnitude between the two groups. Secondary objectives will be the comparison of the success rate of high-flow oxygen therapy compared to traditional airway management by mechanical ventilation. The success rate will be defined as blood pressure of carbon dioxide (PaCO2) \<= 65 mmHg and/or peripheral oxygen saturation (SpO2) \>= 94% throughout the procedure, in the absence of adverse events (haemodynamic alteration, dyspnea, discomfort). The data will be analyzed according to an intention-to-treat principle. Continuous variables with repeated measurements will be compared with a mixed-effect linear regression model. Normality of distribution will be verified with the Shapiro-Wilk test. Continuous variables will be compared with Student t- or Mann-Whitney test; categorical variables with the Chi-square test.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

May 23, 2022

Last Update Submit

December 6, 2022

Conditions

Laryngeal Disease

Keywords

general anesthesiahfncoNIRS

Outcome Measures

Primary Outcomes (1)

  • NIRS

    Average values of frontal cerebral tissue oxygen saturation

    each five minutes from anesthesia induction up to the end of surgery

Secondary Outcomes (1)

  • The success rate of high-flow oxygen therapy compared to traditional airway management by mechanical ventilation.

    each five minutes from anesthesia induction up to the end of surgery

Study Arms (2)

High Flow Oxygen Therapy

EXPERIMENTAL

Surgery conducted under High Flow Oxygen Therapy

Device: THRIVE

Mechanical ventilation

ACTIVE COMPARATOR

Surgery conducted under orotracheal intubation and mechanical ventilation

Device: mechanical ventilation

Interventions

THRIVEDEVICE

Apneic ventilation

High Flow Oxygen Therapy
mechanical ventilationDEVICE

mechanical ventilation in Positive Pressure

Mechanical ventilation

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I and II. Scheduled for Microlaryngeal surgery

You may not qualify if:

  • age \< 18 years;
  • pregnancy status;
  • NYHA class \> III;
  • BMI \> 30;
  • pre-existing cardiac arrhythmias;
  • high risk of inhalation;
  • neuromuscular diseases or metabolite accumulation;
  • refusal of informed consent or impossibility to express it.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabio Sbaraglia

Roma, 00135, Italy

RECRUITING

MeSH Terms

Conditions

Laryngeal Diseases

Interventions

Tobacco Use Cessation DevicesRespiration, Artificial

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAirway ManagementResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • fabio sbaraglia, phD

    Fondazione Policlinico Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

fabio sbaraglia, Ph.D

CONTACT

3497730144fabio.sbaraglia@policlinicogemelli.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 1, 2022

Study Start

September 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)