Bariatric Surgery CandidateNCT04389047
Comparison of Two Mechanical Ventilation Modes on Oxygenisation
An observational study of Bariatric Surgery Candidate and Mechanical Ventilation, run by Bagcilar Training and Research Hospital.
Trial summary
Comparison the effect of two different mechanical ventilation modes on tissue oxygenization. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Mechanical Ventilation, Hypoxia
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2012to 30 Mar 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study population involves the elective bariatric surgery patients who have body mass index between 35 and 50 kg/m2.
Who may be able to join
- Patients with Body Mass Index 35 - 50 kg/m2 Patients classified as American Society of Anesthesiologist (ASA) 1-2-3 classification Patients elected for Bariatric surgery
Who cannot join
- Patients who wants to reject of study participation Patients who has any surgical complication during the surgery period Patients with decompensated cardiac failure Patients with Moderate or Severe obstructive/restrictive lung disease Patients with Reynaud disease Patients with Buerger phenomena Patients whıo has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test
About this study
Official title: Comparison of Two Mechanical Ventilation Strategies on Tissue Oxygenization of Patients Undergoing Bariatric Surgery
Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.
Read the detailed description
Aim of the study is to evaluate and compare the effects of two different mechanical ventilation modes as Volume Controlled Mechanical Ventilation (VCV) and Pressure Controlled Mechanical Ventilation (PCV) on non invasive tissue oxygenization levels of patients who scheduled for bariatric surgery.
- Keywords
- bariatric surgery, tissue oxygenization, ventilation
- Medical subject headings
- Hypoxia, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenization
Peroperative Non invazive technique of Superficial Tissue Oxygenization
Measured: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Oxygenization-2
Post operative Non invazive technique of Superficial Tissue Oxygenization
Measured: post operative 1. hour - 4. hour - 8. hour - 12. hour - 24.hour
Arterial blood gas analysis
Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation
Measured: Peroperative 0. minute - 30. minute - 60. minute
Arterial blood gas analysis-2
Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation
Measured: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Peripheral oxygen saturation
Peripheral Oxygen Saturation (SpO2)
Measured: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Peripheral oxygen saturation-2
Peripheral Oxygen Saturation (SpO2)
Measured: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Secondary outcomes (3)
Peroperative hemodynamic measurements
Heart rate, Mean Arterial Blood Pressure
Measured: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Postoperative hemodynamic measurements
Heart rate, Mean Arterial Blood Pressure
Measured: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Carbondioxide
End tidal Carbondioxide measurement
Measured: peroperative 15. minute - 30. minute - 45. minute - 60. minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start10 Jan 2012
- Primary completion30 Mar 2013
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389047
- Sponsor's protocol ID
- 01.02.2013-228
- Status last verified
- May 2020
- First submitted
- 20 Jan 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Mechanical Ventilation Strategies on Tissue Oxygenization of Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04389047
- Acronym / sponsor ID
- 01.02.2013-228
- Keywords
- bariatric surgery, tissue oxygenization, ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 10 Jan 2012 (actual)
- Primary completion
- 30 Mar 2013 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 15 May 2020 (actual)
- 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.
Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.
Detailed description
Aim of the study is to evaluate and compare the effects of two different mechanical ventilation modes as Volume Controlled Mechanical Ventilation (VCV) and Pressure Controlled Mechanical Ventilation (PCV) on non invasive tissue oxygenization levels of patients who scheduled for bariatric surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study population involves the elective bariatric surgery patients who have body mass index between 35 and 50 kg/m2.
Key inclusion criteria (1 listed)
- Patients with Body Mass Index 35 - 50 kg/m2 Patients classified as American Society of Anesthesiologist (ASA) 1-2-3 classification Patients elected for Bariatric surgery
Key exclusion criteria (1 listed)
- Patients who wants to reject of study participation Patients who has any surgical complication during the surgery period Patients with decompensated cardiac failure Patients with Moderate or Severe obstructive/restrictive lung disease Patients with Reynaud disease Patients with Buerger phenomena Patients whıo has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oxygenization
Time frame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Peroperative Non invazive technique of Superficial Tissue Oxygenization
Oxygenization-2
Time frame: post operative 1. hour - 4. hour - 8. hour - 12. hour - 24.hour
Post operative Non invazive technique of Superficial Tissue Oxygenization
Arterial blood gas analysis
Time frame: Peroperative 0. minute - 30. minute - 60. minute
Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation
Arterial blood gas analysis-2
Time frame: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Lactate, Ph, Arterial oxygen pressure, Arterial Carbondioxide pressure, Oxygen Saturation
Peripheral oxygen saturation
Time frame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation-2
Time frame: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Peripheral Oxygen Saturation (SpO2)
3 secondary outcomes
Peroperative hemodynamic measurements
Time frame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
Postoperative hemodynamic measurements
Time frame: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Carbondioxide
Time frame: peroperative 15. minute - 30. minute - 45. minute - 60. minute
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 15 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Mechanical Ventilation, run by Bagcilar Training and Research Hospital.
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 1 inclusion and 1 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 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Oxygenization (time frame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 May 2020.