THRIVE Apneic Ventilation With Standardized Airway Management During General Anesthesia.

• ClinicalTrials.gov Identifier: NCT03797859
• Recruitment Status: Unknown
• First Posted: January 9, 2019
• Last Update Posted: January 23, 2019
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Michael Seltz Kristensen, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment
Apnea; Ventilation Therapy; Complications; Respiratory Acidosis	Procedure: Apneic ventilation

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 36 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 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.
• Actual Study Start Date: January 8, 2019
• Estimated Primary Completion Date: May 1, 2019
• Estimated Study Completion Date: June 1, 2019

Groups and Cohorts

Intervention Details:

• Procedure: Apneic ventilation
  Ventilation by THRIVE

Outcome Measures

Primary Outcome Measures :

1. Respiratory acidosis [ Time Frame: Max. 60 minutes ]
   Development of respiratory acidosis (pH < 7.15 or paCO2 > 12) over time on study

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for non-laryngeal surgery in general anesthesia, where intubation is not mandatory.

Criteria

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

Contacts and Locations

Locations

Denmark

Rigshospitalet

Copenhagen, Hoevdstaden, Denmark, 2100

Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

• Principal Investigator: Michael S Kristensen, MD; Senior consultant, Rigshospitalet

More Information

• Responsible Party: Michael Seltz Kristensen, SENIOR CONSULTANT, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03797859
• Other Study ID Numbers: H-18017844
• First Posted: January 9, 2019
• Last Update Posted: January 23, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Acidosis, Respiratory; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases