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THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.

Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03797859
Enrollment
36
Registered
2019-01-09
Start date
2019-01-08
Completion date
2019-06-01
Last updated
2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Respiratory Acidosis, Ventilation Therapy; Complications

Brief summary

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion. We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.

Detailed description

THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time. Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed. We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise \> 12 kPa will lead to cessation of THRIVE.

Interventions

PROCEDUREApneic ventilation

Ventilation by THRIVE

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Adult (age over 18 years) 2. Elective surgery where intubation is not mandatory 3. The patient can understand the information about the study and give their informed written consent of participation

Exclusion criteria

1. ASA (American Society of Anaesthesiologists class) \> 3 2. NYHA (New York Heart Association class) \> 2 3. BMI \> 30 kg/m2 4. Symptomatic respiratory disease 5. Symptomatic cardiac disease 6. Evidence of arteriosclerotic disease 7. Neuromuscular disease 8. Pregnancy 9. Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score \> 4) 10. Known or suspected nasal congestion/stenosis or catharalia

Design outcomes

Primary

MeasureTime frameDescription
Respiratory acidosisMax. 60 minutesDevelopment of respiratory acidosis (pH \< 7.15 or paCO2 \> 12) over time on study

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026