Anesthesia Intubation ComplicationNCT03591432
A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
A study testing Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) and Facemask ventilation in people with Anesthesia Intubation Complication and Postoperative Complications, run by Tao Zhang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Anesthesia Intubation Complication, Postoperative Complications
- What is being tested?
- Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) and Facemask ventilation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2018to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who had severe respiratory disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Transnasal humidified rapid insufflation ventilatory exchange (THRIVE), Facemask ventilation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)Device
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.
Facemask ventilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE | Experimental | Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia. Receives: Device: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) |
| Facemask | Active comparator | Using facemask technique in elderly patients undergoing induction of anesthesia. Receives: Device: Facemask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative respiratory complications
Measured: 14 days after surgery
Extended apnoeic period
Measured: during induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591432
- Sponsor's protocol ID
- THRIVE-ELDERLY
- Status last verified
- Jul 2018
- First submitted
- 7 Jul 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21447488Frerk 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.
PubMed 26556848Nishimura 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.
PubMed 25866645
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03591432
- Acronym / sponsor ID
- THRIVE-ELDERLY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE | Experimental | Device: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia. |
| Facemask | Active comparator | Device: Facemask ventilationUsing facemask technique in elderly patients undergoing induction of anesthesia. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who had severe respiratory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)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. | Device | THRIVE |
| Facemask ventilationNowadays 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. | Device | Facemask |
Primary outcome
Postoperative respiratory complications
Time frame: 14 days after surgery
Extended apnoeic period
Time frame: during induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Background: PubMed 21447488Cook 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.
- Background: PubMed 26556848Frerk 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.
- Background: PubMed 25866645Nishimura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) and Facemask ventilation in people with Anesthesia Intubation Complication and Postoperative Complications, run by Tao Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative respiratory complications (time frame: 14 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591432, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.