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08 February 2012
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| [ Print-friendly version ] |
| Effect of early mobilisation on respiratory complications following abdominal surgery |
| ISRCTN | ISRCTN28048472 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of early mobilisation on respiratory complications following abdominal surgery |
| Scientific title | Effect of post-operative early mobilisation on pulmonary complications and hospital stay: a randomised trial |
| Acronym | N/A |
| Serial number at source | sm110208/00 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | Pending as of 12/02/2008: Ethics committee requires investigators to have registered with ISRCTN before considering their applications. |
| Study design | Parallel-group, single blinded, single centre, randomised clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Elective upper and lower gastrointestinal (GI) surgery |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/05/2008 |
| Anticipated end date | 01/05/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 200 (100 in each group - upper and lower GI surgery) |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
1. HDU stay
2. Hospital stay |
| Sources of funding | Chief Scientist Office (CSO) (UK) - research grant pending |
| Trial website | |
| Publications | |
| Contact name | Mr Sami Shimi |
| Address |
Dundee University and Medical School
Ninewells Hospital |
| City/town | Dundee |
| Zip/Postcode | DD1 9SY |
| Country | United Kingdom |
| Sponsor | University of Dundee (UK) |
| Address |
c/o Mr S Shimi
Ninewells Hospital Ninewells Avenue |
| City/town | Dundee |
| Zip/Postcode | DD1 9SY |
| Country | United Kingdom |
| Sponsor website: | http://www.dundee.ac.uk/ |
| Date applied | 11/02/2008 |
| Last edited | 11/04/2008 |
| Date ISRCTN assigned | 11/04/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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