- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03591432
A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
July 19, 2018 updated by: Tao Zhang
A Randomised Controlled Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) Pre-oxygenation and Apneic Oxygenation With Facemask Pre-oxygenation and Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
Induction of general anaesthesia in patients undergoing emergency surgery can be challenging, because of the often suboptimal circumstances under which anaesthesia has to be delivered, as well as potential physiological derangements caused by their underlying illness, especially in elderly patients.
Pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia.
In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction.
However, these options for oxygenation are limited.
Facemask ventilation has a perceived risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents.
Nasal cannulae have been recommended as an alternative method of delivering continuous oxygen during induction of anaesthesia.
The Aim of this study is to compare the effect of transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation with facemask oxygenation on extended apnoeic period and postoperative respiratory complications in elderly patients undergoing induction of anaesthesia.
Study Overview
Status
Unknown
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Guangzhou, China
- First Affiliated Hospital, Sun Yat-Sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who required induction of general anaesthesia for emergency surgery, whose routine clinical care required arterial blood gas sampling, and who were competent to give consent were recruited.
Exclusion Criteria:
- Patients who had severe respiratory disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: THRIVE
Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia.
|
Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is a new technique that is available for use in critically ill patients and in patients with difficult airways.
The technique combines the benefits of apneic oxygenation and CPAP with a reduction in CO2 levels through gaseous mixing and flushing of the dead space.
THRIVE is administered through a standard, commercially available, nasal, high-flow oxygen delivery system.
Insufflation of O2 up to 70 L/min via a purpose-made nasal cannula is used initially to provide preoxygenation, which can be continued during intravenous induction until a definitive airway is secured.
The THRIVE technique has been demonstrated to appreciably prolong the safe duration of apnea while avoiding increase in CO2.
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Active Comparator: Facemask
Using facemask technique in elderly patients undergoing induction of anesthesia.
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Nowadays pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia; this potentially extends the time available for securing the airway before hypoxaemia to 6 min.
In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postoperative respiratory complications
Time Frame: 14 days after surgery
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14 days after surgery
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Extended apnoeic period
Time Frame: during induction of anesthesia
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during induction of anesthesia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
- Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
- Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2018
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
July 7, 2018
First Submitted That Met QC Criteria
July 7, 2018
First Posted (Actual)
July 19, 2018
Study Record Updates
Last Update Posted (Actual)
July 20, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THRIVE-ELDERLY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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