Intubation; Difficult or FailedNCT06459076
Application of THRIVE in Burn Children With Suspected Difficult Airway
A study testing Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in people with Intubation; Difficult or Failed, run by Shuxiu Wang.
Trial summary
In order to improve intubation conditions in burn children, our aim is to investigate the efficacy of transnasal humidified rapid-insufflation ventilatory exchange technique（THRIVE) in children aged between 0 and 18 years who with head, face, and neck injuries by fire, scalding, chemical, electric,explosions, and… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to May 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- < 18 years
- ASA Grade I ~ III
- Children with head, face and neck scald or burn or flame or electrical c hemical or other
Who cannot join
- Refusal or failure to sign an informed consent
- Proposed to transnasal intubation
- Fracture of the nasal bone, nasal bleeding, nasal deformity or obstruction
- Tracheotomy status or severe head, face and neck burn or burn scar (difficult airway)
- Unsuitable for rapid sequence induction
- Basicranial fracture
Show all 9Show fewer
- Cyanotic congenital heart defect
- At risk of malignant hyperthermia
- And is participating in other clinical studies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Application of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) in Burn Children With Suspected Difficult Airway：A Single-center, Randomized Controlled Study
In order to improve intubation conditions in burn children, our aim is to investigate the efficacy of transnasal humidified rapid-insufflation ventilatory exchange technique（THRIVE) in children aged between 0 and 18 years who with head, face, and neck injuries by fire, scalding, chemical, electric,explosions, and others. We hypothesise that THRIVE increases first attempt success without hypoxemia in intubation of children and compared with routine practice.
Does the THRIVE can prolong apnoea time and delay the onset of desaturation to increase the success rate of the first tracheal intubation without desaturation?
Read more
Researchers will compare THRIVE group with Routine care group to see successful intubation on the first attempt without desaturation.
Participants will received intravenous anesthesia induction, followed by 2-3 minutes preoxygenation, before intubation, the mask was removed from the children's face and a THRIVE nasal plug was placed. During intubation, the Routine care group had no oxygen supply,and the THRIVE group will be maintained throughout the apnoeic period with selected flow rates during intubation attempts.
Read the detailed description
The incidence of burns is four times higher in children than in adults: burn injuries account for about 25% of all paediatric hospitalisations. Approximately 70 percent of children who attend hospital with burns or scalds are less than five years of age. The most common cause is hot liquids. Direct heat and steam injury to the upper airway can lead to marked swelling of the face, tongue, epiglottis, and glottic opening, resulting in airway obstruction,especially for these who burned with head,face and neck. Dressings and nasogastric tubes may make face mask seal difficult, facial wounds may be painful, and exudate and topical antibiotics may make for a slippery surface and difficult for anesthesiologist to holding the mask during preoxygenation phase. However,In children, awake intubation is not a viable option. Therefore, intubation is often attempted after Rapid Sequence Intubation (RSI) by set up a vein line after inhalation anesthesia in the operating room. But the lower functional residual capacity and greater metabolic demand of children made the onset of desaturation in apnoeic children occurs much faster than in adults at induction of anaesthesia and is known to be age dependent. If the desaturation occurs, oxygen mask is often required to manually assist ventilation, until SPO2 recovery after another attempt to intubation. Attempting more than two tracheal intubations in children with difficult endotracheal intubation is associated with a high failure rate and increased incidence of complications.
Preoxygenation does not supply an ongoing gas exchange and therefore there is an urgent need for newer methods to continue improved oxygenation during the apnoeic phase.Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) has potential in pre-oxygenation for RSI anaesthesia since it provides high-flow humidified oxygen through nasal cannulae and allows continued peri-laryngoscopy oxygen delivery during apnoea.
Therefore, investigator propose the hypothesis that children with head, face, and neck burns or thermal scalds use THRIVE during endotracheal intubation after anesthesia induction, It can prolong the safe apnoea oxygenation time and increase the success rate of the first intubation without SPO2 decrease ≤90%.
No sedative was applied before patients entering the operating room. All patients were put in the"sniffing" position with a 2-2.5 cm pad placed under shoulder in order to maintain upper airway patency. Intravenous anesthesia was induced with fentanyl 2ug/kg-1 and propofol 2-3mg/kg-1 and vecuronium 0.1 mg/kg-1, respectively,(for children without or with difficulty in set up vein line, 8% sevoflurane was inhaled, and after I.V. access was established,Sevoflurane were discontinued,followed by Intravenous induction), (The preoxygenation phase is defined as the period in preparation for intubation where oxygen is delivered to The patient to maximize oxygen concentration in the functional residual capacity of The lung), and wait 2-3 min for vecuronium to takes effect after reaching end-expiratory oxygen saturation > 90%,the manual ventilation is stopped and according to different groups, different intervention was performed. Routine care group: after stopping manual ventilation, the inestigators immediately removed the mask and placed the nasal plug in place but without oxygen supply, and the anesthesiologist began to intubation; THRIVE group: after stopping manual ventilation, the investigators immediately ceasing assisted ventilation, the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using The Optiflow THRIVETM system. The flow rates applied were as follows: 0-15kg, 2litres KG-1 Min-1; 15-30kg, 35litres Min-1; 30-50kg, 40litres Min-1; and \& GT; 50kg, 50litres Min-1,and start to tracheal intubation.
If SPO2 ≤ 90% appears during intubation, then perform manual ventilation immediately until SPO2 returned to 100% endotracheal intubation was performed again and recorded as second attempt intubation.
Monitoring of anesthetic depth was not possible because The surgical site involved The head and face.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)
- Keywords
- THRIVE, burn children, airway, intubation
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
Immediately after ceasing assisted ventilation, before intubation the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using the Optiflow THRIVETM system. The flow rates applied were as follows: 0-15 kg, 2 litres kg-1 min-1；15-30 kg, 35 litres min-1; 30-50 kg, 40 litres min-1; and>50 kg, 50 litres min-1.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care group | No intervention | After induction of general intravenous anesthesia, 100% oxygen mask ventilation was used for pre-oxygenation, wait 2-3 min to vecuronium take effect and reaching end-expiratory oxygen saturation > 90%, the Optiflow THRIVETM system nasal plug is placed in the proper position, but without oxygen supply, and the tracheal intubation is started. |
| THRIVE group | Experimental | After induction of general intravenous anesthesia, 100% oxygen mask ventilation was used for pre-oxygenation, wait 2-3 min to vecuronium take effect and reaching end-expiratory oxygen saturation > 90%, Immediately after ceasing assisted ventilation, the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using the(Transnasal humidified rapid-insufflation ventilatory exchange, THRIVE) Optiflow THRIVE TM system. The flow rates applied were as follows: 0-15 kg, 2 litres kg-1 min-1；15-30 kg, 35 litres min-1; 30-50 kg, 40 litres min-1; and>50 kg, 50 litres min-1,and the tracheal intubation is started Receives: Device: Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful intubation on the first attempt without physiological instability
Physiological instability is defined as SPO2≤90% at any time after induction of anesthesia until endotracheal intubation is completed.
A successful first attempt intubation is defined as a successful intubation at first attempt without any desaturation (SpO2≤90% or saturation difference ≥10% for who after pre-oxygenation SpO2 cannot reach 100%).
Successful intubation was defined as completion of the intubation attempt with correct placement of the endotracheal tube, as confirmed by the detection of expired carbon dioxide with a colorimetric detector.
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
Rate of hypoxemia; time to and duration of desaturation during the intubation attempt; the duration and number of intubation attempts; nadir SPO2 and heart rate during intubation attempt.
Time to desaturation was defined as the time in seconds from ceasing assisted ventilation until the SpO2 first dropped below 90%.
The duration of desaturation the time from the initial drop below 90% until the SpO2 rose above 100% again.
An intubation attempt was defined as the insertion of the laryngoscope blade beyond the patient's lips until its removal from the patient's mouth, whether or not an attempt was made to insert an endotracheal tube. or where there is a change in operator during the procedure even if the device is not removed.
Intubation time was defined as the time from the start of laryngoscopy, when the blade was introduced between the teeth, until the first breath with the tracheal tube in place, verified by capnography.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuxiu Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuxiu Wang, The First Affiliated Hospital of Air Force Medical University
- Investigators
- shuxiu wang, PH.D, Principal investigator, The Xijing Hospital of Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459076
- Sponsor's protocol ID
- 1stAHAirforceMedicalU
- Status last verified
- Jul 2024
- First submitted
- 1 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legrand M, Barraud D, Constant I, Devauchelle P, Donat N, Fontaine M, Goffinet L, Hoffmann C, Jeanne M, Jonqueres J, Leclerc T, Lefort H, Louvet N, Losser MR, Lucas C, Pantet O, Roquilly A, Rousseau AF, Soussi S, Wiramus S, Gayat E, Blet A. Management of severe thermal burns in the acute phase in adults and children. Anaesth Crit Care Pain Med. 2020 Apr;39(2):253-267. doi: 10.1016/j.accpm.2020.03.006. Epub 2020 Mar 5.
PubMed 32147581Jeschke MG, Herndon DN. Burns in children: standard and new treatments. Lancet. 2014 Mar 29;383(9923):1168-78. doi: 10.1016/S0140-6736(13)61093-4. Epub 2013 Sep 11.
PubMed 24034453Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.
PubMed 25485468Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
PubMed 26705976Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
PubMed 25388828Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.
PubMed 28100527Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.
PubMed 35476651Overmann KM, Boyd SD, Zhang Y, Kerrey BT. Apneic oxygenation to prevent oxyhemoglobin desaturation during rapid sequence intubation in a pediatric emergency department. Am J Emerg Med. 2019 Aug;37(8):1416-1421. doi: 10.1016/j.ajem.2018.10.030. Epub 2018 Oct 18.
PubMed 30401594Kerrey BT, Rinderknecht AS, Geis GL, Nigrovic LE, Mittiga MR. Rapid sequence intubation for pediatric emergency patients: higher frequency of failed attempts and adverse effects found by video review. Ann Emerg Med. 2012 Sep;60(3):251-9. doi: 10.1016/j.annemergmed.2012.02.013. Epub 2012 Mar 15.
PubMed 22424653
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) in Burn Children With Suspected Difficult Airway：A Single-center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06459076
- Acronym / sponsor ID
- 1stAHAirforceMedicalU
- Conditions
- Intubation; Difficult or Failed
- Keywords
- THRIVE, burn children, airway, intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shuxiu WangUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 14 Jun 2024 (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.
In order to improve intubation conditions in burn children, our aim is to investigate the efficacy of transnasal humidified rapid-insufflation ventilatory exchange technique（THRIVE) in children aged between 0 and 18 years who with head, face, and neck injuries by fire, scalding, chemical, electric,explosions, and others. We hypothesise that THRIVE increases first attempt success without hypoxemia in intubation of children and compared with routine practice.
Does the THRIVE can prolong apnoea time and delay the onset of desaturation to increase the success rate of the first tracheal intubation without desaturation?
Researchers will compare THRIVE group with Routine care group to see successful intubation on the first attempt without desaturation.
Participants will received intravenous anesthesia induction, followed by 2-3 minutes preoxygenation, before intubation, the mask was removed from the children's face and a THRIVE nasal plug was placed. During intubation, the Routine care group had no oxygen supply,and the THRIVE group will be maintained throughout the apnoeic period with selected flow rates during intubation attempts.
Detailed description
The incidence of burns is four times higher in children than in adults: burn injuries account for about 25% of all paediatric hospitalisations. Approximately 70 percent of children who attend hospital with burns or scalds are less than five years of age. The most common cause is hot liquids. Direct heat and steam injury to the upper airway can lead to marked swelling of the face, tongue, epiglottis, and glottic opening, resulting in airway obstruction,especially for these who burned with head,face and neck. Dressings and nasogastric tubes may make face mask seal difficult, facial wounds may be painful, and exudate and topical antibiotics may make for a slippery surface and difficult for anesthesiologist to holding the mask during preoxygenation phase. However,In children, awake intubation is not a viable option. Therefore, intubation is often attempted after Rapid Sequence Intubation (RSI) by set up a vein line after inhalation anesthesia in the operating room. But the lower functional residual capacity and greater metabolic demand of children made the onset of desaturation in apnoeic children occurs much faster than in adults at induction of anaesthesia and is known to be age dependent. If the desaturation occurs, oxygen mask is often required to manually assist ventilation, until SPO2 recovery after another attempt to intubation. Attempting more than two tracheal intubations in children with difficult endotracheal intubation is associated with a high failure rate and increased incidence of complications.
Preoxygenation does not supply an ongoing gas exchange and therefore there is an urgent need for newer methods to continue improved oxygenation during the apnoeic phase.Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) has potential in pre-oxygenation for RSI anaesthesia since it provides high-flow humidified oxygen through nasal cannulae and allows continued peri-laryngoscopy oxygen delivery during apnoea.
Therefore, investigator propose the hypothesis that children with head, face, and neck burns or thermal scalds use THRIVE during endotracheal intubation after anesthesia induction, It can prolong the safe apnoea oxygenation time and increase the success rate of the first intubation without SPO2 decrease ≤90%.
No sedative was applied before patients entering the operating room. All patients were put in the"sniffing" position with a 2-2.5 cm pad placed under shoulder in order to maintain upper airway patency. Intravenous anesthesia was induced with fentanyl 2ug/kg-1 and propofol 2-3mg/kg-1 and vecuronium 0.1 mg/kg-1, respectively,(for children without or with difficulty in set up vein line, 8% sevoflurane was inhaled, and after I.V. access was established,Sevoflurane were discontinued,followed by Intravenous induction), (The preoxygenation phase is defined as the period in preparation for intubation where oxygen is delivered to The patient to maximize oxygen concentration in the functional residual capacity of The lung), and wait 2-3 min for vecuronium to takes effect after reaching end-expiratory oxygen saturation > 90%,the manual ventilation is stopped and according to different groups, different intervention was performed. Routine care group: after stopping manual ventilation, the inestigators immediately removed the mask and placed the nasal plug in place but without oxygen supply, and the anesthesiologist began to intubation; THRIVE group: after stopping manual ventilation, the investigators immediately ceasing assisted ventilation, the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using The Optiflow THRIVETM system. The flow rates applied were as follows: 0-15kg, 2litres KG-1 Min-1; 15-30kg, 35litres Min-1; 30-50kg, 40litres Min-1; and \& GT; 50kg, 50litres Min-1,and start to tracheal intubation.
If SPO2 ≤ 90% appears during intubation, then perform manual ventilation immediately until SPO2 returned to 100% endotracheal intubation was performed again and recorded as second attempt intubation.
Monitoring of anesthetic depth was not possible because The surgical site involved The head and face.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care group | No intervention | –After induction of general intravenous anesthesia, 100% oxygen mask ventilation was used for pre-oxygenation, wait 2-3 min to vecuronium take effect and reaching end-expiratory oxygen saturation > 90%, the Optiflow THRIVETM system nasal plug is placed in the proper position, but without oxygen supply, and the tracheal intubation is started. |
| THRIVE group | Experimental | Device: Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)After induction of general intravenous anesthesia, 100% oxygen mask ventilation was used for pre-oxygenation, wait 2-3 min to vecuronium take effect and reaching end-expiratory oxygen saturation > 90%, Immediately after ceasing assisted ventilation, the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using the(Transnasal humidified rapid-insufflation ventilatory exchange, THRIVE) Optiflow THRIVE TM system. The flow rates applied were as follows: 0-15 kg, 2 litres kg-1 min-1；15-30 kg, 35 litres min-1; 30-50 kg, 40 litres min-1; and>50 kg, 50 litres min-1,and the tracheal intubation is started |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- < 18 years
- ASA Grade I ~ III
- Children with head, face and neck scald or burn or flame or electrical c hemical or other
Key exclusion criteria (9 listed)
- Refusal or failure to sign an informed consent
- Proposed to transnasal intubation
- Fracture of the nasal bone, nasal bleeding, nasal deformity or obstruction
- Tracheotomy status or severe head, face and neck burn or burn scar (difficult airway)
- Unsuitable for rapid sequence induction
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)Immediately after ceasing assisted ventilation, before intubation the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using the Optiflow THRIVETM system. The flow rates applied were as follows: 0-15 kg, 2 litres kg-1 min-1；15-30 kg, 35 litres min-1; 30-50 kg, 40 litres min-1; and>50 kg, 50 litres min-1. | Device | THRIVE group |
Primary outcome
Rate of successful intubation on the first attempt without physiological instability
Time frame: through study completion, an average of 2 years
Physiological instability is defined as SPO2≤90% at any time after induction of anesthesia until endotracheal intubation is completed. A successful first attempt intubation is defined as a successful intubation at first attempt without any desaturation (SpO2≤90% or saturation difference ≥10% for who after pre-oxygenation SpO2 cannot reach 100%). Successful intubation was defined as completion of the intubation attempt with correct placement of the endotracheal tube, as confirmed by the detection of expired carbon dioxide with a colorimetric detector.
1 secondary outcome
Rate of hypoxemia; time to and duration of desaturation during the intubation attempt; the duration and number of intubation attempts; nadir SPO2 and heart rate during intubation attempt.
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Results publication: PubMed 32147581Legrand M, Barraud D, Constant I, Devauchelle P, Donat N, Fontaine M, Goffinet L, Hoffmann C, Jeanne M, Jonqueres J, Leclerc T, Lefort H, Louvet N, Losser MR, Lucas C, Pantet O, Roquilly A, Rousseau AF, Soussi S, Wiramus S, Gayat E, Blet A. Management of severe thermal burns in the acute phase in adults and children. Anaesth Crit Care Pain Med. 2020 Apr;39(2):253-267. doi: 10.1016/j.accpm.2020.03.006. Epub 2020 Mar 5.
- Results publication: PubMed 24034453Jeschke MG, Herndon DN. Burns in children: standard and new treatments. Lancet. 2014 Mar 29;383(9923):1168-78. doi: 10.1016/S0140-6736(13)61093-4. Epub 2013 Sep 11.
- Results publication: PubMed 25485468Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.
- Results publication: PubMed 26705976Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
- Results publication: PubMed 25388828Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.
- Results publication: PubMed 28100527Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.
- Results publication: PubMed 35476651Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.
- Results publication: PubMed 30401594Overmann KM, Boyd SD, Zhang Y, Kerrey BT. Apneic oxygenation to prevent oxyhemoglobin desaturation during rapid sequence intubation in a pediatric emergency department. Am J Emerg Med. 2019 Aug;37(8):1416-1421. doi: 10.1016/j.ajem.2018.10.030. Epub 2018 Oct 18.
- Results publication: PubMed 22424653Kerrey BT, Rinderknecht AS, Geis GL, Nigrovic LE, Mittiga MR. Rapid sequence intubation for pediatric emergency patients: higher frequency of failed attempts and adverse effects found by video review. Ann Emerg Med. 2012 Sep;60(3):251-9. doi: 10.1016/j.annemergmed.2012.02.013. Epub 2012 Mar 15.
- PubMed ID:32147581Link provided by the sponsor.
- PubMed ID:24034453Link provided by the sponsor.
- PubMed ID:25485468Link provided by the sponsor.
- PubMed ID:26705976Link provided by the sponsor.
- PubMed ID:25388828Link provided by the sponsor.
- PubMed ID:28100527Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
shuxiu wang, PH.D principal investigator
The Xijing Hospital of Air Force Military Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in people with Intubation; Difficult or Failed, run by Shuxiu Wang.
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 3 inclusion and 9 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact dandan cheng, PH.D (+86 029 84775343, wangshuxiuzi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful intubation on the first attempt without physiological instability (time frame: through study completion, an average of 2 years). 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 NCT06459076, which also lists 9 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 5 Jul 2024.