Comparison of the effects of spontaneous breathing trial with T-piece versus pressure-support ventilation in patients recovering from cardiac surgery: a randomised controlled pilot study

ISRCTN	ISRCTN53959736
DOI	https://doi.org/10.1186/ISRCTN53959736
Secondary identifying numbers	N0205182184

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Ms Lee Moi Hew
Scientific

ITU
London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom

Phone	+44 (0)20 8983 2209
Email	leemoi.hew@bartsandthelondon.nhs.uk

Study design	Randomised controlled pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	To compare the mean levels of anxiety reported by two groups of patients using a Visual Analogue Scale (VAS) at specific time points during spontaneous breathing trials with: 1. The T-piece method, or 2. Pressure-support ventilation (PSV) of 10 cm H2O with positive end expiratory pressure (PEEP) 5 cm H2O
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Spontaneous breathing after ventilation
Intervention	Patients are randomised to: 1. The T-piece method 2. Pressure-support ventilation (PSV) of 10 cm H2O with positive end expiratory pressure (PEEP) 5 cm H2O
Intervention type	Procedure/Surgery
Primary outcome measure	Anxiety scores before operation, at PSV of 10 cm H2O with PEEP of 5 cm H2O, 30-minute after PSV of 10 cm H2O with PEEP of 5 cm H2O, before extubation, one hour after extubation and before discharge from ICU.
Secondary outcome measures	No secondary outcome measures
Overall study start date	22/03/2006
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	45
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	22/03/2006
Date of final enrolment	30/09/2006

ITU

London
E2 9JX
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barts and The London NHS Trust (UK)

No information available

NHS R & D Support Funding (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan