Effect of early mobilisation on respiratory complications following abdominal surgery
| ISRCTN | ISRCTN28048472 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28048472 |
| Secondary identifying numbers | sm110208/00 |
- Submission date
- 11/02/2008
- Registration date
- 11/04/2008
- Last edited
- 26/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Mr Sami Shimi
Scientific
Scientific
Dundee University and Medical School
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Parallel-group, single blinded, single centre, randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of post-operative early mobilisation on pulmonary complications and hospital stay: a randomised trial |
| Study objectives | Early mobilisation is used by many centres around the country, with physiotherapists hypothesising that movement will encourage deeper breaths due to increasing oxygen demand, improve muscle strength and patient confidence, reduce post-operative pulmonary complications (PPCs) and ultimately reduce length of stay. The aim of this study is to establish whether goal oriented early post-operative mobilisation would reduce post-operative pulmonary complications and reduce hospital length of stay in patients who have had elective abdominal surgery. |
| Ethics approval(s) | Pending as of 12/02/2008: Ethics committee requires investigators to have registered with ISRCTN before considering their applications. |
| Health condition(s) or problem(s) studied | Elective upper and lower gastrointestinal (GI) surgery |
| Intervention | 1. Control group: routine post-operative physiotherapy 2. Intervention group: routine post-operative physiotherapy and goal directed mobilisation Patients will be encouraged to achieve progressive mobility goals as shown: 1. Up to sit out of bed 2. Mobilise 5 m assisted 3. Mobilise 20 m assisted 4. Mobilise 40 m independently Each patient will be treated once each day, unless clinical need indicates further respiratory intervention. All patients will be reviewed for a minimum of 7 days post operatively, and until they have returned to their previous level of function. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Post-operative pulmonary complications: both the number of patients with these complication and the severity will be taken into account 2. Pulmonary function tests: the forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) will be collected pre-operatively and post-operatively on days 3, 5 and prior to hospital discharge |
| Secondary outcome measures | 1. HDU stay 2. Hospital stay |
| Overall study start date | 01/05/2008 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 (100 in each group - upper and lower GI surgery) |
| Key inclusion criteria | 1. Elective patients 2 Abdominal surgery 3. Booked in High Dependency Unit (HDU) 4. Ability to give written informed consent prior to study participation 5 Male or female patients over 18 years old 6. Ability to communicate with the study personnel and to comply with the study requirements 7. Ability to mobilise (freely or with walking aid) 8. American Society of Anaesthesiologists (ASA) grade 1 - 3 inclusive |
| Key exclusion criteria | 1. Inability to communicate with the study personnel and to comply with the study requirements (mobility) 2. Unable to give consent 3. Under 18 years of age 4. Patients admitted to Intensive Care Unit (ICU) prior to HDU 5. Patients with impaired mobility (bed bound or wheel chair bound) 6. ASA grade 4 or above |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee University and Medical School
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
Ninewells Hospital
Ninewells Avenue
Dundee
DD1 9SY
Scotland
United Kingdom
| Website | http://www.dundee.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Chief Scientist Office
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| 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 |
Editorial Notes
26/04/2016: No publications found, verifying study status with principal investigator
