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Sedation for Non-invasive Ventilation in Blunt Chest Trauma

Primary Purpose

Chest Trauma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride
Ketamine Hydrochloride
Placebo
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chest Trauma focused on measuring Sedation - noninvasive ventilation-ketamine- dexmedetomidine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • AHU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

Ketamine

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Duration of non-invasive ventilation (NIV) session
duration that patient can withhold NIV comfortably

Secondary Outcome Measures

Richmond agitation sedation score (RASS)
The hourly measurements by nurses of RASS score for pain and respiratory discomfort during each NIV session.
Visual analogue scale
the hourly measurements of self-rated 10-cm VAS for pain during each NIV session.
length of ICU stay
Through study completion, an average of 1 year

Full Information

First Posted
November 7, 2021
Last Updated
July 26, 2022
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05175781
Brief Title
Sedation for Non-invasive Ventilation in Blunt Chest Trauma
Official Title
Dexmedetomidine Versus Ketamine to Facilitate Non-invasive Ventilation After Blunt Chest Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Trauma
Keywords
Sedation - noninvasive ventilation-ketamine- dexmedetomidine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Other Intervention Name(s)
Precedex
Intervention Description
is a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain parts of the brain.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
Ketalar
Intervention Description
Ketamine is an NMDA receptor antagoni
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nacl .9%
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Duration of non-invasive ventilation (NIV) session
Description
duration that patient can withhold NIV comfortably
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Richmond agitation sedation score (RASS)
Description
The hourly measurements by nurses of RASS score for pain and respiratory discomfort during each NIV session.
Time Frame
8 hours
Title
Visual analogue scale
Description
the hourly measurements of self-rated 10-cm VAS for pain during each NIV session.
Time Frame
8 hours
Title
length of ICU stay
Description
Through study completion, an average of 1 year
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
AHU
City
Aswan
ZIP/Postal Code
81511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31319192
Citation
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.
Results Reference
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PubMed Identifier
28096063
Citation
Bouzat 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.
Results Reference
background
PubMed Identifier
27481750
Citation
Erstad 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.
Results Reference
background
PubMed Identifier
28105598
Citation
Weerink 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.
Results Reference
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PubMed Identifier
31076142
Citation
Jabaudon 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.
Results Reference
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PubMed Identifier
23575437
Citation
Mion 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.
Results Reference
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PubMed Identifier
21812509
Citation
Hoy 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.
Results Reference
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Sedation for Non-invasive Ventilation in Blunt Chest Trauma

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