Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
10/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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.

Publication citations

Additional files

Editorial Notes