Laparoscopic SurgeryNCT00944086
Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment
An observational study of Laparoscopic Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 27 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Recruitment Manoeuvre
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2008to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study has been applied on 32 cases which have undergone laparoscopic cholecystectomy.
Who may be able to join
None listed.
Who cannot join
- Patients, who were older than 65 years,
- had respiratory system and cardiovascular diseases,
- used medication that could affect the respiratory function or smokers have been excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Clinical Study:Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment Manoeuvres
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
Read the 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.
- Conditions
- Laparoscopic Surgery
- Being tested
- Recruitment Manoeuvre
- Keywords
- Recruitment, Oxygen Concentration, pneumoperitoneum, laparoscopy
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment ManoeuvreOther
Recruitment Manoeuvre
| Study group | Role | What they receive |
|---|---|---|
| Recruitment Manoeuvre ,Laparoscopy | Not described Receives: Other: Recruitment Manoeuvre |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944086
- Sponsor's protocol ID
- Akaratas
- Status last verified
- Aug 2009
- First submitted
- 21 Jul 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Study:Oxygen Concentration Should be Kept at the Lowest Possible Level During Recruitment Manoeuvres
- ClinicalTrials.gov ID
- NCT00944086
- Acronym / sponsor ID
- Akaratas
- Conditions
- Laparoscopic Surgery
- Keywords
- Recruitment, Oxygen Concentration, pneumoperitoneum, laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recruitment Manoeuvre ,Laparoscopy | – | Other: Recruitment Manoeuvre |
Who may qualify
- Ages
- 27 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study has been applied on 32 cases which have undergone laparoscopic cholecystectomy.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients, who were older than 65 years,
- had respiratory system and cardiovascular diseases,
- used medication that could affect the respiratory function or smokers have been excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recruitment ManoeuvreRecruitment Manoeuvre | Other | Recruitment Manoeuvre ,Laparoscopy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009; AzTrials last refreshed its copy on 31 Oct 2026.