Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/06/2020
Date assigned
23/06/2020
Last edited
22/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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, 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

http://Www.hospital.pof.gov.pk

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

Publication citations

Additional files

Editorial Notes

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