Chest TraumaNCT05175781
Sedation for Non-invasive Ventilation in Blunt Chest Trauma
A study testing Dexmedetomidine Hydrochloride and Ketamine Hydrochloride in people with Chest Trauma, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Effectiveness of sedation using dexmedetomidine and ketamine to facilitate non-invasive ventilation sessions which improve overall outcome after blunt chest trauma Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Trauma
- What is being tested?
- Dexmedetomidine Hydrochloride and Ketamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2022to 26 Jul 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All blunt chest trauma patients with:
- More than 3 rib fractures, pulmonary contusion,
- hypoxemia or hypercapnia, or respiratory rate 20/ min despite an optimized intravenous analgesia ( paracetamol 1gm i.v. 6hourly and ketolac 30mg i.v. 8 hourly)
- No indication of mechanical ventilation
Who cannot join
- Patients < 18 years old,
- admitted under mechanical ventilation
- admitted more than 24 h after trauma or from another hospital,
- patients with less than 3 ribs fractures
- patients did not receive CT-scan
- Patients in whom alpha-2 agonists or ketamine are contraindicated
- Patients who will require an intubation during the study period for a life-threatening condition or emergency surgery or agitation as defined by a Richmond Agitation Sedation Scale (RASS) score higher than +2 will also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Ketamine to Facilitate Non-invasive Ventilation After Blunt Chest Trauma
Effectiveness of sedation using dexmedetomidine and ketamine to facilitate non-invasive ventilation sessions which improve overall outcome after blunt chest trauma
Read the detailed description
Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is considered liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized.
Blunt traumas are commonly secondary to motor vehicle accidents, falls, and crush or blast injuries. They are the most common type of thoracic trauma, accounting for over 90%, and are often associated with rib fractures, haemothorax, pneumothorax, and pulmonary contusions.
In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing acute respiratory distress syndrome (ARDS) after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.
Notably, pain control seems a crucial endpoint in our success to deliver non-invasive ventilation to patients with chest trauma, when feasible as a pivotal component of patient care after chest trauma, along with non-invasive ventilation. In this context, the role of intensivist doctors is thus to provide optimal control of chest wall pain, respiratory comfort, agitation, and anxiety as a prerequisite to reduce the incidence of NIV failure in this trauma population.
In this context, dexmedetomidine could be an alternative to improve NIV tolerance. Dexmedetomidine is a short-acting alpha-2 adrenoreceptor agonist that provides sedation and analgesia with no significant respiratory depression and a reduced risk of delirium.
Ketamine has several advantages compared with conventional sedatives such as preserving pharyngeal and laryngeal protective reflexes, lowering airway resistance, increasing lung compliance, and being less likely to produce respiratory depression. It causes sympathetic stimulation, which is also unlike other sedatives and analgesics.
However, no studies have estimated the superiority of dexmedetomidine or Ketamine to improve analgesia and non-invasive ventilation tolerance in patients with blunt chest
The patients will be randomly allocated into 3 groups, the allocation of the treatment order will determine by means of a computer-generated random table.
Group C: will receive placebo infusion (0.9% sodium chloride solution) Group D: will receive dexmedetomidine infusion Group K: will receive ketamine infusion
- Conditions
- Chest Trauma
- Being tested
- Dexmedetomidine Hydrochloride, Ketamine Hydrochloride, Placebo
- Keywords
- Sedation - noninvasive ventilation-ketamine- dexmedetomidine
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called Precedex
is a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain parts of the brain.
Ketamine HydrochlorideDrug
Also called Ketalar
Ketamine is an NMDA receptor antagoni
PlaceboDrug
Also called Nacl .9%
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | patients will receive two NIV sessions during which intravenous continuous infusion of dexmedetomidine will be given.
The infusion was initiated 60 min prior to NIV at the same rate for all treatments, corresponding to 0.7 mcg/kg/h of dexmedetomidine without a loading dose. Dexmedetomidine will then titrate by 0.2 mcg/kg/h every 60 min (up to a maximum dose of 1.3 mcg/kg/h) to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two NIV sessions accounting for 1-h contextual half-life of dexmedetomidine. Patients received neither tested drug nor NIV during this 6-h interval. Receives: Drug: Dexmedetomidine Hydrochloride |
| Ketamine | Active comparator | patients will receive two NIV sessions during which intravenous continuous infusion of ketamine will be given.
The infusion was initiated 60 min prior to NIV at the same rate for all treatments, infusion of ketamine will be at the dose of 0.20 mg/kg/h (or 3.3 mg/kg/min). to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two NIV sessions . Patients received neither tested drug nor NIV during this 6-h interval.
Following the start of the infusion, the patient could have a morphine dose if the 10-cm Visual Analog Scale (VAS) exceeded 3. Receives: Drug: Ketamine Hydrochloride |
| Placebo | Placebo comparator | patients will receive two NIV sessions during which intravenous continuous infusion of placebo (0.9% sodium chloride solution) will be given.
The infusion was initiated 60 min prior to NIV at the same rate for all treatments, corresponding to 0.7 mcg/kg/h of dexmedetomidine without a loading dose. will then titrate by 0.2 mcg/kg/h every 60 min (up to a maximum dose of 1.3 mcg/kg/h) to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two . Patients received neither tested drug nor NIV during this 6-h interval.
Following the start of any infusion, the patient could have a morphine dose if the 10-cm Visual Analog Scale (VAS) exceeded 3. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of non-invasive ventilation (NIV) session
duration that patient can withhold NIV comfortably
Measured: 8 hours
Secondary outcomes (3)
Richmond agitation sedation score (RASS)
The hourly measurements by nurses of RASS score for pain and respiratory discomfort during each NIV session.
Measured: 8 hours
Visual analogue scale
the hourly measurements of self-rated 10-cm VAS for pain during each NIV session.
Measured: 8 hours
length of ICU stay
Through study completion, an average of 1 year
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start18 Jan 2022
- Primary completion20 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chest TraumaStudies 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, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Fahmy Mahmoud, PhD, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175781
- Sponsor's protocol ID
- 494/12/20
- Status last verified
- Jul 2022
- First submitted
- 7 Nov 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deletombe B, Trouve-Buisson T, Godon A, Falcon D, Giorgis-Allemand L, Bouzat P, Bosson JL, Payen JF. Dexmedetomidine to facilitate non-invasive ventilation after blunt chest trauma: A randomised, double-blind, crossover, placebo-controlled pilot study. Anaesth Crit Care Pain Med. 2019 Oct;38(5):477-483. doi: 10.1016/j.accpm.2019.06.012. Epub 2019 Jul 15.
PubMed 31319192Bouzat P, Raux M, David JS, Tazarourte K, Galinski M, Desmettre T, Garrigue D, Ducros L, Michelet P; Expert's group; Freysz M, Savary D, Rayeh-Pelardy F, Laplace C, Duponq R, Monnin Bares V, D'Journo XB, Boddaert G, Boutonnet M, Pierre S, Leone M, Honnart D, Biais M, Vardon F. Chest trauma: First 48hours management. Anaesth Crit Care Pain Med. 2017 Apr;36(2):135-145. doi: 10.1016/j.accpm.2017.01.003. Epub 2017 Jan 16.
PubMed 28096063Erstad BL, Patanwala AE. Ketamine for analgosedation in critically ill patients. J Crit Care. 2016 Oct;35:145-9. doi: 10.1016/j.jcrc.2016.05.016. Epub 2016 May 25.
PubMed 27481750Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.
PubMed 28105598Jabaudon M, Blondonnet R, Constantin JM. ARDS in patients with chest trauma: Better safe than sorry. Anaesth Crit Care Pain Med. 2019 Jun;38(3):221-222. doi: 10.1016/j.accpm.2019.04.006. No abstract available.
PubMed 31076142Mion G, Villevieille T. Ketamine pharmacology: an update (pharmacodynamics and molecular aspects, recent findings). CNS Neurosci Ther. 2013 Jun;19(6):370-80. doi: 10.1111/cns.12099. Epub 2013 Apr 10.
PubMed 23575437Hoy SM, Keating GM. Dexmedetomidine: a review of its use for sedation in mechanically ventilated patients in an intensive care setting and for procedural sedation. Drugs. 2011 Jul 30;71(11):1481-501. doi: 10.2165/11207190-000000000-00000.
PubMed 21812509
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Ketamine to Facilitate Non-invasive Ventilation After Blunt Chest Trauma
- ClinicalTrials.gov ID
- NCT05175781
- Acronym / sponsor ID
- 494/12/20
- Conditions
- Chest Trauma
- Keywords
- Sedation - noninvasive ventilation-ketamine- dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 4 Jan 2022 (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.
Effectiveness of sedation using dexmedetomidine and ketamine to facilitate non-invasive ventilation sessions which improve overall outcome after blunt chest trauma
Detailed description
Chest trauma remains an issue for health services for both severe and apparently mild trauma management. Severe chest trauma is associated with high mortality and is considered liable for 25% of mortality in multiple traumas. Moreover, mild trauma is also associated with significant morbidity especially in patients with preexisting conditions. Thus, whatever the severity, a fast-acting strategy must be organized.
Blunt traumas are commonly secondary to motor vehicle accidents, falls, and crush or blast injuries. They are the most common type of thoracic trauma, accounting for over 90%, and are often associated with rib fractures, haemothorax, pneumothorax, and pulmonary contusions.
In order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (NIV) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay Among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. Indeed, interventions aimed at preventing acute respiratory distress syndrome (ARDS) after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.
Notably, pain control seems a crucial endpoint in our success to deliver non-invasive ventilation to patients with chest trauma, when feasible as a pivotal component of patient care after chest trauma, along with non-invasive ventilation. In this context, the role of intensivist doctors is thus to provide optimal control of chest wall pain, respiratory comfort, agitation, and anxiety as a prerequisite to reduce the incidence of NIV failure in this trauma population.
In this context, dexmedetomidine could be an alternative to improve NIV tolerance. Dexmedetomidine is a short-acting alpha-2 adrenoreceptor agonist that provides sedation and analgesia with no significant respiratory depression and a reduced risk of delirium.
Ketamine has several advantages compared with conventional sedatives such as preserving pharyngeal and laryngeal protective reflexes, lowering airway resistance, increasing lung compliance, and being less likely to produce respiratory depression. It causes sympathetic stimulation, which is also unlike other sedatives and analgesics.
However, no studies have estimated the superiority of dexmedetomidine or Ketamine to improve analgesia and non-invasive ventilation tolerance in patients with blunt chest
The patients will be randomly allocated into 3 groups, the allocation of the treatment order will determine by means of a computer-generated random table.
Group C: will receive placebo infusion (0.9% sodium chloride solution) Group D: will receive dexmedetomidine infusion Group K: will receive ketamine infusion
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine Hydrochloridepatients will receive two NIV sessions during which intravenous continuous infusion of dexmedetomidine will be given. The infusion was initiated 60 min prior to NIV at the same rate for all treatments, corresponding to 0.7 mcg/kg/h of dexmedetomidine without a loading dose. Dexmedetomidine will then titrate by 0.2 mcg/kg/h every 60 min (up to a maximum dose of 1.3 mcg/kg/h) to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two NIV sessions accounting for 1-h contextual half-life of dexmedetomidine. Patients received neither tested drug nor NIV during this 6-h interval. |
| Ketamine | Active comparator | Drug: Ketamine Hydrochloridepatients will receive two NIV sessions during which intravenous continuous infusion of ketamine will be given. The infusion was initiated 60 min prior to NIV at the same rate for all treatments, infusion of ketamine will be at the dose of 0.20 mg/kg/h (or 3.3 mg/kg/min). to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two NIV sessions . Patients received neither tested drug nor NIV during this 6-h interval. Following the start of the infusion, the patient could have a morphine dose if the 10-cm Visual Analog Scale (VAS) exceeded 3. |
| Placebo | Placebo comparator | Drug: Placebopatients will receive two NIV sessions during which intravenous continuous infusion of placebo (0.9% sodium chloride solution) will be given. The infusion was initiated 60 min prior to NIV at the same rate for all treatments, corresponding to 0.7 mcg/kg/h of dexmedetomidine without a loading dose. will then titrate by 0.2 mcg/kg/h every 60 min (up to a maximum dose of 1.3 mcg/kg/h) to maintain a RASS score between 0 and 3. A 6-h washout period was observed between two . Patients received neither tested drug nor NIV during this 6-h interval. Following the start of any infusion, the patient could have a morphine dose if the 10-cm Visual Analog Scale (VAS) exceeded 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- More than 3 rib fractures, pulmonary contusion,
- hypoxemia or hypercapnia, or respiratory rate 20/ min despite an optimized intravenous analgesia ( paracetamol 1gm i.v. 6hourly and ketolac 30mg i.v. 8 hourly)
- No indication of mechanical ventilation
Key exclusion criteria (7 listed)
- Patients < 18 years old,
- admitted under mechanical ventilation
- admitted more than 24 h after trauma or from another hospital,
- patients with less than 3 ribs fractures
- patients did not receive CT-scan
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 |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: Precedexis a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain parts of the brain. | Drug | Dexmedetomidine |
| Ketamine HydrochlorideAlso: KetalarKetamine is an NMDA receptor antagoni | Drug | Ketamine |
| PlaceboAlso: Nacl .9%Normal saline | Drug | Placebo |
Primary outcome
Duration of non-invasive ventilation (NIV) session
Time frame: 8 hours
duration that patient can withhold NIV comfortably
3 secondary outcomes
Richmond agitation sedation score (RASS)
Time frame: 8 hours
Visual analogue scale
Time frame: 8 hours
length of ICU stay
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Background: PubMed 31319192Deletombe B, Trouve-Buisson T, Godon A, Falcon D, Giorgis-Allemand L, Bouzat P, Bosson JL, Payen JF. Dexmedetomidine to facilitate non-invasive ventilation after blunt chest trauma: A randomised, double-blind, crossover, placebo-controlled pilot study. Anaesth Crit Care Pain Med. 2019 Oct;38(5):477-483. doi: 10.1016/j.accpm.2019.06.012. Epub 2019 Jul 15.
- Background: PubMed 28096063Bouzat P, Raux M, David JS, Tazarourte K, Galinski M, Desmettre T, Garrigue D, Ducros L, Michelet P; Expert's group; Freysz M, Savary D, Rayeh-Pelardy F, Laplace C, Duponq R, Monnin Bares V, D'Journo XB, Boddaert G, Boutonnet M, Pierre S, Leone M, Honnart D, Biais M, Vardon F. Chest trauma: First 48hours management. Anaesth Crit Care Pain Med. 2017 Apr;36(2):135-145. doi: 10.1016/j.accpm.2017.01.003. Epub 2017 Jan 16.
- Background: PubMed 27481750Erstad BL, Patanwala AE. Ketamine for analgosedation in critically ill patients. J Crit Care. 2016 Oct;35:145-9. doi: 10.1016/j.jcrc.2016.05.016. Epub 2016 May 25.
- Background: PubMed 28105598Weerink MAS, Struys MMRF, Hannivoort LN, Barends CRM, Absalom AR, Colin P. Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine. Clin Pharmacokinet. 2017 Aug;56(8):893-913. doi: 10.1007/s40262-017-0507-7.
- Background: PubMed 31076142Jabaudon M, Blondonnet R, Constantin JM. ARDS in patients with chest trauma: Better safe than sorry. Anaesth Crit Care Pain Med. 2019 Jun;38(3):221-222. doi: 10.1016/j.accpm.2019.04.006. No abstract available.
- Background: PubMed 23575437Mion G, Villevieille T. Ketamine pharmacology: an update (pharmacodynamics and molecular aspects, recent findings). CNS Neurosci Ther. 2013 Jun;19(6):370-80. doi: 10.1111/cns.12099. Epub 2013 Apr 10.
- Background: PubMed 21812509Hoy SM, Keating GM. Dexmedetomidine: a review of its use for sedation in mechanically ventilated patients in an intensive care setting and for procedural sedation. Drugs. 2011 Jul 30;71(11):1481-501. doi: 10.2165/11207190-000000000-00000.
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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 Dexmedetomidine Hydrochloride and Ketamine Hydrochloride in people with Chest Trauma, run by Aswan University Hospital at 1 site in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jul 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of non-invasive ventilation (NIV) session (time frame: 8 hours). 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 NCT05175781, which also lists 7 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 27 Jul 2022.