Contact information
Type
Scientific
Primary contact
Ms Lee Moi Hew
ORCID ID
Contact details
ITU
London Chest Hospital
Bonner Road
London
E2 9JX
United Kingdom
+44 (0)20 8983 2209
leemoi.hew@bartsandthelondon.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205182184
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
22/03/2006
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
45
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
22/03/2006
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
ITU
London
E2 9JX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R & D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
No publication intended as of 2006. The results were presented in a poster at the 2007 RCN International Nursing Research Conference.