Plain English Summary
Background and study aims
Traumatic brain injury (TBI) represents the leading cause of morbidity and mortality in individuals under the age of 45 in the world. Ventilatory management of a brain-injured patient is challenging.
In this study IntelliVent ASV (Adaptive Support ventilation) mode ventilation is used for mechanically ventilating patients with head Injury and compared to patients with head Injury who are ventilated with conventional mode of ventilation (SIMV, Synchronized Intermittent mandatory ventilation).
Who can participate?
Head injury patients requiring mechanical ventilation
What does the study involve?
Patients were assigned to either IntelliVent ASV or SIMV and followed up for 48 hours.
What are the possible benefits and risks of participating?
Benefits: the role of IntelliVent in head injury patients secures better outcomes in terms of decreased morbidity and mortality. This means less ICU stay, early wean off, decreased Hospital stay. It also means decreased workload for doctors and staff alike (as it is automated)
RISKS the role of IntelliVent mode being superior on conventional modes proves the other patients were neglected (in terms of decreased therapeutic care)
Where is the study run from?
Pakistan Ordinance Factory Hospital
When is the study starting and how long is it expected to run for?
November 2018 to April 2019
Who is funding the study?
Pakistan Ordinance Factory Hospital
Who is the main contact?
Dr Sadia Imran, S.s.imran2723@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sadia Imran
ORCID ID
Contact details
Pakistan Ordinance Factory Hospital
House #4
Champa road
opposite sir Syed school
Central park area
Wah cantt
47070
Pakistan
+92 (0)3448869927
S.s.imran2723@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Comparative analysis of closed loop IntelliVent mode ventilation in head injury patients to conventional SIMV ventilation modes
Acronym
Study hypothesis
Closed loop INTELLIVENT ASV mode secures better outcomes in head injury patients as compared to conventional mode (SIMV)
Ethics approval
Approved 01/06/2017 by Ethical Review Committee (ERC) of P.O.F Hospital (The Quaid Avenue, Wah Cantt, 47040, Pakistan; +92 322 2054452; Imr59us81@hotmail.com), ref: none provided
Study design
Single centre randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Head injury
Intervention
Patients with head injury fulfilling the inclusion criteria were selected and randomly allocated into two groups. Informed consent was taken from all the patients falling in inclusion criteria. Randomization of patients was based on the sequence of admission in the ITC. Even-numbered patients were allocated automated closed-loop INTELLIVENT mode and odd-numbered of patients were given conventional SIMV mode. Patients were blinded of the allocation sequence. SpO2 was measured with a finger probe i.e., pulse plethysmography. The PETCO2 was measured by a mainstream capnograph connected to the ventilatory circuit. The PETCO2 was measured throughout ventilation. All ventilation parameters were noted at 6 hrs interval and averaged over 48hrs. The data was entered in the proforma.
Each patient was individually assessed and evaluated according to the departmental protocols. This included history, physical examination, GCS scoring, radiological investigations, serum and blood baseline investigations and arterial blood gases evaluation.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
End tidal CO2 was measured as a primary outcome of effective ventilation. The ETCO2 was measured at 6 hrs interval and then averaged over 48 hrs and filled on the questionnaire. ETCO2 for first 48 hrs was taken as a measure of ventilation.
Secondary outcome measures
Prevention of secondary insult during stay assessed with variables as the length of ICU stay, ICU mortality and hospital mortality using patient records
Overall trial start date
01/04/2017
Overall trial end date
30/04/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Head injury with rapidly deteriorating GCS within 24 hrs
2. Patients with GCS less than 8/15 requiring mechanical ventilation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. GCS of 3/15 with head injury
2. Blunt trauma to the chest
3. Lung pathologies
4. Extremes of ages, infants, neonates and elderly
5. Co-morbidities such as DM, HTN
Recruitment start date
01/11/2018
Recruitment end date
30/04/2019
Locations
Countries of recruitment
Pakistan
Trial participating centre
P.O.F Hospital (Pakistan Ordinance Factory Hospital)
Intensive Therapeutic Care department
The Quaid Avenue
Wah Cantt
Wah Cantt
47040
Pakistan
Sponsor information
Organisation
Pakistan Ordinance Factory Hospital
Sponsor details
House #4
Champa road
opposite sir Syed school
Central park area
Wah cantt
47070
Pakistan
+92 (0)51 905525 265
comdhosp@pof.gov.pk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Pakistan Ordinance Factory Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
07/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list