HypoxemiaNCT04981990
Single Lung Ventilation Versus Two Lung Ventilation
A study testing Single lung ventilation by double lumen endotracheal tube and Two lung ventilation by conventional single lumen endotracheal tube in people with Hypoxemia and Single Lung Ventilation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Hypoxia in single lung ventilation versus two lung ventilation in video assisted lung surgeries Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypoxemia, Single Lung Ventilation
- What is being tested?
- Single lung ventilation by double lumen endotracheal tube and Two lung ventilation by conventional single lumen endotracheal tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 25 Aug 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group: Adult patients from age of 21 years to 60 years
- Sex: Both sexes
- ASA Classification: patients with ASA classification II, III.
- Elective lung surgeries using video assisted thoracoscopic surgeries.
Who cannot join
- Patients refuse to give informed consent.
- ASA Classification: ASA IV.
- Failure of thoracoscopic surgeries and continue as open thoracotomy
- Patients with ischemic heart diseases, where hypoxemia might be preexisting, or patient be more vulnerable to hypoxemia whatever the technique or time of hypoxia.
- Emergency lung surgeries.
- Patients underwent previous lung surgeries of any cause.
- Patients with pathology to the non-operated side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Lung Ventilation Versus Two Lung Ventilation in Video Assisted Lung Surgeries
Hypoxia in single lung ventilation versus two lung ventilation in video assisted lung surgeries
Read the detailed description
Incidence of hypoxia in single lung ventilation by double lumen endotracheal tube "of choice in lung surgeries" versus incidence of hypoxia in two lung ventilation by conventional single lumen endotracheal tube "intermittent two lung ventilation"
- Conditions
- Hypoxemia, Single Lung Ventilation
- Being tested
- Single lung ventilation by double lumen endotracheal tube, Two lung ventilation by conventional single lumen endotracheal tube
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single lung ventilation by double lumen endotracheal tubeProcedure or surgery
Single lung ventilation using double lumen endotracheal tube and isolation of the operated lung during surgery to create ideal surgical field
Two lung ventilation by conventional single lumen endotracheal tubeProcedure or surgery
Intermittent two lung ventilation so that no significant hypoxia occurs with creating optimum surgical field
| Study group | Role | What they receive |
|---|---|---|
| Single lung ventilation | Active comparator | Using double lumen endotracheal tube and lung isolation Receives: Procedure: Single lung ventilation by double lumen endotracheal tube |
| Two lung ventilation | Active comparator | Using conventional single lumen endotracheal tube and intermittent two lung ventilation Receives: Procedure: Two lung ventilation by conventional single lumen endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypoxemia
Hypoxemia in single and two lung ventilation by serial arterial blood gases
Measured: Intraoperative to first 24 hours post operative
Secondary outcomes (3)
Incidence of failure to correct Hypoxemia in single lung ventilation
Stop lung isolation and procedure using two lung ventilation to correct hypoxia
Measured: Intraoperative
Incidence of failure of two lung ventilation to create optimum surgical field
Frequent stopping of ventilation and the surgent can't access the surgical field easily
Measured: Intraoperative
Incidence of post operative complications
Any associated complications
Measured: First 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Mar 2021
- Primary completion25 Aug 2021
- Study completion25 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two equal groups: the first group undergoing lung surgeries with single lung ventilation by double lumen endotracheal tube, the second group undergoing lung surgeries with two lung ventilation using conventional single lumen endotracheal tube
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdellatif, Ain Shams University
- Investigators
- Esraa Abdellatif, M.B., B.Ch., Principal investigator, Anesthesiology departmentOmar El safty, MD, Study chair, Anesthesiology departmentSalwa Omar, MD, Study director, Anesthesiology departmentMohamed Taeimah, MD, Study director, Anesthesiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981990
- Sponsor's protocol ID
- Anesth
- Status last verified
- Aug 2021
- First submitted
- 22 Apr 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study data will be open to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Lung Ventilation Versus Two Lung Ventilation in Video Assisted Lung Surgeries
- ClinicalTrials.gov ID
- NCT04981990
- Acronym / sponsor ID
- Anesth
- Conditions
- Hypoxemia, Single Lung Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (estimated)
- First posted
- 29 Jul 2021 (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.
Hypoxia in single lung ventilation versus two lung ventilation in video assisted lung surgeries
Detailed description
Incidence of hypoxia in single lung ventilation by double lumen endotracheal tube "of choice in lung surgeries" versus incidence of hypoxia in two lung ventilation by conventional single lumen endotracheal tube "intermittent two lung ventilation"
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two equal groups: the first group undergoing lung surgeries with single lung ventilation by double lumen endotracheal tube, the second group undergoing lung surgeries with two lung ventilation using conventional single lumen endotracheal tube
| Arm | Type | Receives |
|---|---|---|
| Single lung ventilation | Active comparator | Procedure: Single lung ventilation by double lumen endotracheal tubeUsing double lumen endotracheal tube and lung isolation |
| Two lung ventilation | Active comparator | Procedure: Two lung ventilation by conventional single lumen endotracheal tubeUsing conventional single lumen endotracheal tube and intermittent two lung ventilation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age group: Adult patients from age of 21 years to 60 years
- Sex: Both sexes
- ASA Classification: patients with ASA classification II, III.
- Elective lung surgeries using video assisted thoracoscopic surgeries.
Key exclusion criteria (7 listed)
- Patients refuse to give informed consent.
- ASA Classification: ASA IV.
- Failure of thoracoscopic surgeries and continue as open thoracotomy
- Patients with ischemic heart diseases, where hypoxemia might be preexisting, or patient be more vulnerable to hypoxemia whatever the technique or time of hypoxia.
- Emergency lung surgeries.
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 |
|---|---|---|
| Single lung ventilation by double lumen endotracheal tubeSingle lung ventilation using double lumen endotracheal tube and isolation of the operated lung during surgery to create ideal surgical field | Procedure or surgery | Single lung ventilation |
| Two lung ventilation by conventional single lumen endotracheal tubeIntermittent two lung ventilation so that no significant hypoxia occurs with creating optimum surgical field | Procedure or surgery | Two lung ventilation |
Primary outcome
Incidence of hypoxemia
Time frame: Intraoperative to first 24 hours post operative
Hypoxemia in single and two lung ventilation by serial arterial blood gases
3 secondary outcomes
Incidence of failure to correct Hypoxemia in single lung ventilation
Time frame: Intraoperative
Incidence of failure of two lung ventilation to create optimum surgical field
Time frame: Intraoperative
Incidence of post operative complications
Time frame: First 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Yes. All study data will be open to other researchers
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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.
Esraa Abdellatif, M.B., B.Ch. principal investigator
Anesthesiology department
Omar El safty, MD study chair
Anesthesiology department
Salwa Omar, MD study director
Anesthesiology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single lung ventilation by double lumen endotracheal tube and Two lung ventilation by conventional single lumen endotracheal tube in people with Hypoxemia and Single Lung Ventilation, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Aug 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Abdellatif (01119895491, esraa301993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypoxemia (time frame: Intraoperative to first 24 hours post operative). 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 25 Aug 2021.