PreoxygenationNCT04070404
Quality of Preoxygenation in Emergency Surgery
An observational study of Preoxygenation and Anaesthesia, run by Vilnius University at 1 site in Lithuania.
Trial summary
Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery. The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoxygenation, Anaesthesia, Emergencies
- How many people
- 200 participants
- Where
- 1 siteLithuania
- Study dates
- 1 May 2019to 1 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients undergoing general anaesthesia for emergency surgery
Who may be able to join
- written informed consent
- patient going for emergency surgery under general anaesthesia
- age > 18 years
Who cannot join
- informed consent refusal
- noneligible for preoxygenation before general anaesthesia
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Clinics
Vilnius
Egle Kontrimaviciute, Assoc. Preofessor, +37052365264, egle.kontrimaviciute@santa.lt
Ruta Januleviciene, MD, +37052365264, ruta.januleviciene2@santa.lt
About this study
Official title: Study of Preoxygenation Quality Prior to General Anesthesia in Emergency Surgery
Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.
The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.
Read the detailed description
Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.
Parameters analysed:
- Preoperative: medical history, physical examination, laboratory findings, anthropometric data
- Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)
- Conditions
- Preoxygenation, Anaesthesia, Emergencies, Surgery
- Keywords
- Anaesthesia, Preoxygenation
- Medical subject headings
- Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficient preoxygenation in preset time
End-tidal oxygen concentration values
Measured: 300 seconds
Secondary outcomes (1)
Factors influencing preoxygenation quality
Medical history, physical status, lab findings, preoxygenation equipment and method
Measured: 300 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 May 2019
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoxygenationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070404
- Sponsor's protocol ID
- 19BMT30
- Status last verified
- Oct 2020
- First submitted
- 23 Aug 2019
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Preoxygenation Quality Prior to General Anesthesia in Emergency Surgery
- ClinicalTrials.gov ID
- NCT04070404
- Acronym / sponsor ID
- 19BMT30
- Conditions
- Preoxygenation, Anaesthesia, Emergencies, Surgery
- Keywords
- Anaesthesia, Preoxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 28 Aug 2019 (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.
Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.
The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.
Detailed description
Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.
Parameters analysed:
- Preoperative: medical history, physical examination, laboratory findings, anthropometric data
- Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients undergoing general anaesthesia for emergency surgery
Key inclusion criteria (3 listed)
- written informed consent
- patient going for emergency surgery under general anaesthesia
- age > 18 years
Key exclusion criteria (2 listed)
- informed consent refusal
- noneligible for preoxygenation before general anaesthesia
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
Efficient preoxygenation in preset time
Time frame: 300 seconds
End-tidal oxygen concentration values
1 secondary outcome
Factors influencing preoxygenation quality
Time frame: 300 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No
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Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask
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Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
Obesity
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Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
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Effect of Preoxygenation Position and Examination Position on Hypoxemia During Painless Gastrointestinal Endoscopy
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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.
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 Preoxygenation and Anaesthesia, run by Vilnius University at 1 site in Lithuania.
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 3 inclusion and 2 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 9 Oct 2020. 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 Lithuania. 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 Egle Kontrimaviciute, Assoc Professor (+37052365264, egle.kontrimaviciute@santa.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficient preoxygenation in preset time (time frame: 300 seconds). 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 9 Oct 2020.