Apnea Clinical Trial - THRIVE Apneic Ventilation With Standardized Airway

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acidosis
Apnea
Respiratory Acidosis
Ventilation Therapy; Complications

Clinical Trial Details

NCT number	NCT03797859
Study type	Observational
Source	Rigshospitalet, Denmark
Contact
Status	Enrolling by invitation
Phase
Start date	January 8, 2019
Completion date	June 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02580526` - Comparison of Mask Ventilation Techniques in Patients Requiring General Anesthesia	N/A
Completed	`NCT02627001` - Nu-Mask Intraoral Airway Device Versus Conventional Bag Valve Mask Ventilation Crossover Trial	Phase 4
Recruiting	`NCT01825473` - Study of Erythromycin in GER-Associated Apnea of the Newborn	N/A
Completed	`NCT02103777` - High Versus Low Dose of Caffeine for Apnea of Prematurity	Phase 3
Completed	`NCT00950287` - Detection of Neonatal Bradycardia	N/A
Recruiting	`NCT00382876` - Identifying the Relative Change in Ventilation in Newborns With Placement in Car Bed or Car Seat	N/A
Completed	`NCT00369759` - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants	N/A
Completed	`NCT04084535` - Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.	N/A
Recruiting	`NCT02968797` - Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation
Completed	`NCT02554110` - Peripheral Nerve Stimulation to Reduce Hypoxic Events	N/A
Not yet recruiting	`NCT04366414` - Breathing Protocol in Breath-hold Divers	N/A
Completed	`NCT05124093` - The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea	N/A
Recruiting	`NCT01994785` - Use of Capnography in EGD and Colonoscopy With Moderate Sedation.	N/A
Completed	`NCT01435486` - Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants	N/A
Completed	`NCT01852929` - Sleep Apnea and Visual Perceptual Skill Learning	N/A
Completed	`NCT00389909` - Dosing Chart for Calculating the First Dose of Doxapram in Premature Infants	Phase 4
Completed	`NCT00188968` - Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.	Phase 3
Not yet recruiting	`NCT05396274` - High Flow Nasal Oxygen Therapy Undergoing Colonoscopy	N/A
Completed	`NCT02800213` - Ventilation Using a Bag Valve Mask With Supplemental External Handle	N/A
Completed	`NCT02375230` - MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms