Sedation for Non-invasive Ventilation in Blunt Chest Trauma

July 26, 2022 updated by: Huda Fahmy Mahmoud, PhD, Aswan University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

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

  • Egypt
      • Aswan, Egypt, 81511
        • AHU

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine

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.
Drug: Dexmedetomidine Hydrochloride
is a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain parts of the brain.
Other Names:
  • Precedex
Active Comparator: Ketamine

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.
Drug: Ketamine Hydrochloride
Ketamine is an NMDA receptor antagoni
Other Names:
  • Ketalar
Placebo Comparator: Placebo

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.
Drug: Placebo
Normal saline
Other Names:
  • Nacl .9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of non-invasive ventilation (NIV) session
Time Frame: 8 hours
duration that patient can withhold NIV comfortably
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Richmond agitation sedation score (RASS)
Time Frame: 8 hours
The hourly measurements by nurses of RASS score for pain and respiratory discomfort during each NIV session.
8 hours
Visual analogue scale
Time Frame: 8 hours
the hourly measurements of self-rated 10-cm VAS for pain during each NIV session.
8 hours
length of ICU stay
Time Frame: 8 days
Through study completion, an average of 1 year
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

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

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 (Actual)

January 18, 2022

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 26, 2022

Study Registration Dates

First Submitted

November 7, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 494/12/20

Drug and device information, study documents

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

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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