Condition category
Injury, Occupational Diseases, Poisoning
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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,

Trial website

Contact information



Primary contact

Dr Sadia Imran


Contact details

Pakistan Ordinance Factory Hospital
House #4
Champa road
opposite sir Syed school
Central park area
Wah cantt
+92 (0)3448869927

Additional identifiers

EudraCT number

Nil known 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


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;, ref: none provided

Study design

Single centre randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Head injury


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

P.O.F Hospital (Pakistan Ordinance Factory Hospital)
Intensive Therapeutic Care department The Quaid Avenue Wah Cantt
Wah Cantt

Sponsor information


Pakistan Ordinance Factory Hospital

Sponsor details

House #4
Champa road
opposite sir Syed school
Central park area
Wah cantt
+92 (0)51 905525 265

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Pakistan Ordinance Factory Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/06/2020: Trial’s existence confirmed by College of Physicians and Surgeons Pakistan