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Randomized Controlled Trial:High-flow Oxygen Therapy and Tracheal Intubation for Laryngeal Microsurgery

NCT05400642 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-08

No results posted yet for this study

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.

Conditions

  • Laryngeal Disease

Interventions

DEVICE

THRIVE

Apneic ventilation

DEVICE

mechanical ventilation

mechanical ventilation in Positive Pressure

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • fabio sbaraglia, phD · Fondazione Policlinico Gemelli IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05400642 on ClinicalTrials.gov