One Lung VentilationNCT01652612
Positive End-expiratory Pressure and Alveolar Recruitment for One Lung Ventilation
A study testing PEEP in people with One Lung Ventilation, run by Yonsei University at 1 site in South Korea.
Trial summary
Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- One Lung Ventilation
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Feb 2013
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- age: 20-75 years
Who cannot join
- moderate to severe impaired respiratory function,
- heart failure,
- patients' refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Positive End-expiratory Pressure and Alveolar Recruitment on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position
Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in patients undergoing thoracic surgery .
Read the detailed description
outcome measures: respiratory parameters (Paw, Ppla, Compliance, Vd/Vt)and oxygenation parameters (PaO2, shunt fraction, Pa-AO2)
- Conditions
- One Lung Ventilation
- Being tested
- PEEP
- Keywords
- positive end expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
8 cmH2O PEEP throughout the period of OLV and 2nd TLV
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | zero PEEP |
| OLV strategy: PEEP | Experimental | 1. apply 8 cm H2O positive end expiratory pressure during one lung ventilation and until the end of surgery Receives: Other: PEEP |
| OLV strategy: PEEP followed by AR | Experimental | 1. alveolar recruitment strategy before one lung ventilation
2. 8 cmH2O positive end expiratory pressure during one lung ventilation and until the end of surgery Receives: Other: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2, number of patients with hypoxia (PaO2< 90mmHg)
blood samplings after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV
Measured: participants will be followed for the duration of anesthesia, an expected average of 3 hours
Secondary outcomes (1)
intrapulmonary shunt
blood sampling after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV
Measured: participants will be followed for the duration of anesthesia, an expected average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One Lung VentilationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongseon Choi, Yonsei University
- Investigators
- Yongseon Choi, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652612
- Sponsor's protocol ID
- 4-2011-0301
- Status last verified
- Jul 2013
- First submitted
- 20 Dec 2011
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Positive End-expiratory Pressure and Alveolar Recruitment on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position
- ClinicalTrials.gov ID
- NCT01652612
- Acronym / sponsor ID
- 4-2011-0301
- Conditions
- One Lung Ventilation
- Keywords
- positive end expiratory pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Jul 2012 (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.
Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in patients undergoing thoracic surgery .
Detailed description
outcome measures: respiratory parameters (Paw, Ppla, Compliance, Vd/Vt)and oxygenation parameters (PaO2, shunt fraction, Pa-AO2)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –zero PEEP |
| OLV strategy: PEEP | Experimental | Other: PEEP1. apply 8 cm H2O positive end expiratory pressure during one lung ventilation and until the end of surgery |
| OLV strategy: PEEP followed by AR | Experimental | Other: PEEP1. alveolar recruitment strategy before one lung ventilation 2. 8 cmH2O positive end expiratory pressure during one lung ventilation and until the end of surgery |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- age: 20-75 years
Key exclusion criteria (3 listed)
- moderate to severe impaired respiratory function,
- heart failure,
- patients' refusal
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 |
|---|---|---|
| PEEP8 cmH2O PEEP throughout the period of OLV and 2nd TLV | Other | OLV strategy: PEEP, OLV strategy: PEEP followed by AR |
Primary outcome
PaO2, number of patients with hypoxia (PaO2< 90mmHg)
Time frame: participants will be followed for the duration of anesthesia, an expected average of 3 hours
blood samplings after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV
1 secondary outcome
intrapulmonary shunt
Time frame: participants will be followed for the duration of anesthesia, an expected average of 3 hours
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 4 Jul 2013.
Related trials for One Lung Ventilation
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
Recruiting
BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery
Pulmonary Resection Surgery, One Lung Ventillation (OLV)
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.
Yongseon Choi principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with One Lung Ventilation, run by Yonsei University at 1 site in South Korea.
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 2 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 4 Jul 2013. 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 South Korea. 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.
What does the primary outcome measure?
PaO2, number of patients with hypoxia (PaO2< 90mmHg) (time frame: participants will be followed for the duration of anesthesia, an expected average of 3 hours). 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 4 Jul 2013.