Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment
| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 21, 2009 |
| Last Updated Date | August 3, 2009 |
| Start Date ICMJE | May 2008 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00944086 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment |
| Official Title ICMJE | A Prospective Randomized Clinical Study:Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment Manoeuvres |
| Brief Summary | In This Study, Our Goal is to Compare the Effects of Recruitment Manoeuvre Which is Applied With Different Oxygen Concentrations on Oxygenation and Respiratory Mechanics During Pneumoperitoneum |
| Detailed Description | Detailed Description: "Recruitment manoeuvre" which has been defined and become popular in the recent years is nowadays widely accepted and applied. The positive effects of the recruitment manoeuvre during and after surgery on respiratory mechanics and oxygenation have been reported. The duration and the applied pressure values of recruitment manoeuvre have been defined well and in detail regarding the definitions for this manoeuvre (1-3). Despite these definitions, no detailed information has been provided on the effects of the oxygen and oxygen concentration during recruitment manoeuvre . Atelectasis develops after the induction of anaesthesia, even in healthy subjects, and is associated with an increase in intraoperative shunt leading to impairment of gas exchange (4). It is well known that in patients, who have undergone mechanical ventilation with high oxygen concentration levels, oxygen replaces the less insoluble nitrogen. Partial oxygen pressure increases with the implementation of oxygen in high concentrations, and the oxygen flow into the blood increases. But when the gas flow into the blood is more than inspired, absorption atelectasis develops in lungs - due to appliance of high oxygen concentration. Atelectasis may also develop due to different reasons such as failure in secretion clearance during the surgery, replacement of nitrogen with inhalation anaesthetics and appliance of pneumoperitoneum. In the recent years, many studies have analyzed the effects of recruitment manoeuvre during pneumoperitoneum and laparoscopic surgery on respiratory mechanics and oxygenation, and reported the benefits of recruitment in these operations (4-6). In this study, our goal is to compare the effects of recruitment manoeuvre which is applied with different oxygen concentrations on oxygenation and respiratory mechanics during pneumoperitoneum. |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | This study has been applied on 32 cases which have undergone laparoscopic cholecystectomy. |
| Condition ICMJE | Laparoscopic Surgery |
| Intervention ICMJE | Other: Recruitment Manoeuvre
Recruitment Manoeuvre |
| Study Group/Cohort (s) | Recruitment Manoeuvre ,Laparoscopy
Intervention: Other: Recruitment Manoeuvre |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | Not Provided |
| Completion Date | August 2008 |
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Exclusion Criteria:
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| Gender | Both |
| Ages | 27 Years to 61 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Turkey |
| Administrative Information | |
| NCT Number ICMJE | NCT00944086 |
| Other Study ID Numbers ICMJE | Akaratas |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Not Provided |
| Study Sponsor ICMJE | Istanbul University |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Istanbul University |
| Verification Date | August 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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