Role of closed loop IntelliVent ventilation mode in head injury patients requiring mechanical ventilation

ISRCTN	ISRCTN10127188
DOI	https://doi.org/10.1186/ISRCTN10127188

Submission date: 18/06/2020
Registration date: 23/06/2020
Last edited: 22/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Sadia Imran
Scientific

Pakistan Ordinance Factory Hospital
House #4, Champa road, opposite sir Syed school
Central park area
Wah cantt
47070
Pakistan

Phone	+92 (0)3448869927
Email	S.s.imran2723@gmail.com

Study information

Study design	Single centre randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparative analysis of closed loop IntelliVent mode ventilation in head injury patients to conventional SIMV ventilation modes
Study objectives	Closed loop INTELLIVENT ASV mode secures better outcomes in head injury patients as compared to conventional mode (SIMV)
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/04/2017
Completion date	30/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key inclusion criteria	1. Head injury with rapidly deteriorating GCS within 24 hrs 2. Patients with GCS less than 8/15 requiring mechanical ventilation
Key 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
Date of first enrolment	01/11/2018
Date of final enrolment	30/04/2019

Locations

Countries of recruitment

Pakistan

Study 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

Pakistan Ordinance Factory Hospital
Hospital/treatment centre

House #4, Champa road, opposite sir Syed school
Central park area
Wah cantt
47070
Pakistan

Phone	+92 (0)51 905525 265
Email	comdhosp@pof.gov.pk
Website	http://Www.hospital.pof.gov.pk

Funders

Funder type

Hospital/treatment centre

Pakistan Ordinance Factory Hospital

No information available

Results and Publications

Intention to publish date	07/07/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high impact peer reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Editorial Notes

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