| Scientific Title of Trial | A study to determine the improvement of oxygenation by adopting the normal sleeping body position in individuals during artificial ventilation | |
| Public Title of Trial (in lay language) | A study to determine the improvement of oxygenation by adopting the normal sleeping body position in individuals during artificial ventilation | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Oxygenation in ventilated patients | |
| What is the research question being addressed? | Can sleeping position influence oxygenation in ventilated patients? | |
| Study design | Single center, single blind, parallel group, randomized controlled trial | |
| Intervention(s) planned | Following randomization, the following will be carried out on the intervention group: 1.Stabilization in semi recumbent position (the normal nursing position in ICU) 2.Patients placed in normal sleeping position (head and arm position) for 1 hour 3.Return to semi recumbent position |
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| Inclusion criteria | Patients receiving mechanical ventilation in SIMV mode | |
| Exclusion criteria | Asthma, COPD, segmental lung pathologies, chest deformities, cerebral oedema with evidence of raised intracranial pressure, clinical conditions that may contraindicate the change of position such as fractures, spinal injuries, haemodynamic instability | |
| Target number / sample size | 174 (87 subjects per group) | |
| Primary outcome(s) | 1. Arterial blood gas readings 2. Arterial oxygen saturation 3. Spontaneous tidal volume 4. Respiratory rate |
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| Primary outcome(s) - time of assessment(s) | At base line and at one hour after adopting the normal sleeping position | |
| Secondary outcome(s) | 1.Time taken to wean from the ventilator 2. Mortality at the discharge from the ICU |
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| Secondary outcome(s) - time of assessment(s) | At the time of weaning from the ventilator and at the time of discharge from the ICU | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/08/2012 | |
| Anticipated end date | 01/01/2013 | |
| Recruitment status | Pending | |
| State of ethics review approval | Approved by the Ethical Review Committee, Faculty of Medicine, University of Peradeniya, Sri Lanka (EC/22/2010) | |
| Funding source(s) | None | |
| Applicant's Email | vasantipinto@yahoo.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr. Vasanthi Pinto
Consultant Anaesthetist , Senior Lecturer Department of Anaesthesiology, Faculty of Medicine, Peradeniya, Sri Lanka 0773662199 081-2389106 vasantipinto@yahoo.com |
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| Primary Study Sponsor/ Organization | Dr. Vasanthi Pinto
Department of Anaesthesiology, Faculty of Medicine, University of Peradeniya, Sri Lanka 0773662199 081-2389106 vasantipinto@yahoo.com |
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| Contact Person for Public Queries | Dr. Vasanthi Pinto Consultant Anaesthetist, Senior Lecturer Department of Anaesthesiology, Faculty of Medicine, University of Peradeniya, Sri Lanka 0773662199 081-2389106 vasantipinto@yahoo.com |
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| Secondary Study Sponsor(s), (if any) | None |
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