AtelectasisNCT06790901
Effects of Anesthesia on Atelectasis
An observational study of Atelectasis and General Aneshesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
We know that respiratory functions of patients are affected under general anaesthesia. Although there are many underlying causes of ventilation-perfusion mismatch in the airways, the main cause is atelectasis during general anaesthesia. Atelectasis occurs in almost all patients receiving general anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, General Aneshesia
- What is being tested?
- LUNG ULTRASOUND
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 12 Jan 2025
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18-65 years old, ASA I-II, who will undergo rhinoplasty, septorhinoplasty operation
Who may be able to join
- 18-65 years old ASA I-II Surgical procedure time between 2 hours and 5 hours in supine position Patients who will undergo rhinoplasty, septorhinoplasty operation Patients whose consent was obtained with an informed consent form
Who cannot join
- Those with a history of malignant hyperthermia,
- People with alcohol or drug addiction,
- Presence of dementia or confusion,
- Uncooperative patients,
- Those with respiratory disease,
- Those with coronary artery disease, congestive heart failure,
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- Patients with unstable blood pressure,
- Significant anaemia, liver or kidney disease,
- Women during pregnancy or lactation,
- Allergy to anaesthetic agents,
- Body mass index (BMI) >30 kg/m2,
- Those with sepsis or bacterial infection, Body temperature below 35°C and above 38°C at control value
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguladk Bulent ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: EVALUATION of PEROPERATIVE ATELECTASIS with LUNG ULTRASOUND SCORE in GENERAL ANAESTHESIA MAINTENANCE METHODS
We know that respiratory functions of patients are affected under general anaesthesia. Although there are many underlying causes of ventilation-perfusion mismatch in the airways, the main cause is atelectasis during general anaesthesia.
Atelectasis occurs in almost all patients receiving general anaesthesia. The main cause of atelectasis is the loss of muscle tone during general anaesthesia. Postoperative atelectasis was described in the last century. It is defined as the closure of the alveoli due to a decrease in inspiratory force and collapse of the lung and the resulting loss of aeration.
Read more
Inhalation anaesthetics have been shown to cause hypoxic pulmonary vasoconstriction in studies. However, not all inhalation anaesthetics affect the airways in the same way.
In patients who will undergo surgical procedures under different general anaesthesia maintenance methods, conditions that disrupt the ventilation-perfusion balance in the lung peroperatively can be diagnosed and monitored early, easily and inexpensively by lung ultrasonography.
Lung ultrasound is a noninvasive, reliable, reliable, radiation-free imaging method that provides instantaneous imaging at the bedside. Lung ultrasound score is a scoring system that provides scoring of the loss of ventilation in the lung. For this purpose, it was aimed to divide both lung tissues into 12 areas and to give a score between 0 and 3 points and to show the severity of the loss of aeration according to the resulting total score.
- Conditions
- Atelectasis, General Aneshesia
- Being tested
- LUNG ULTRASOUND
- Keywords
- Lung Ultrasound Score, general anesthesia, Atelectasis, Inhalation agents
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUNG ULTRASOUNDProcedure or surgery
Determination of atelectsis By Lung Ultrasound Score
| Study group | Role | What they receive |
|---|---|---|
| Group Total IV anesthesia | Not described Receives: Procedure: LUNG ULTRASOUND | |
| Group Sevoflurane | Not described Receives: Procedure: LUNG ULTRASOUND | |
| Group Desflurane | Not described Receives: Procedure: LUNG ULTRASOUND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroperative Atelectasis
Measured: from induction to postoperative 1st hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start15 Sep 2023
- Primary completion30 Aug 2024
- Study completion12 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguzhan Karayaka, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790901
- Sponsor's protocol ID
- 2023/16-6
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION of PEROPERATIVE ATELECTASIS with LUNG ULTRASOUND SCORE in GENERAL ANAESTHESIA MAINTENANCE METHODS
- ClinicalTrials.gov ID
- NCT06790901
- Acronym / sponsor ID
- 2023/16-6
- Conditions
- Atelectasis, General Aneshesia
- Keywords
- Lung Ultrasound Score, general anesthesia, Atelectasis, Inhalation agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 24 Jan 2025 (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.
We know that respiratory functions of patients are affected under general anaesthesia. Although there are many underlying causes of ventilation-perfusion mismatch in the airways, the main cause is atelectasis during general anaesthesia.
Atelectasis occurs in almost all patients receiving general anaesthesia. The main cause of atelectasis is the loss of muscle tone during general anaesthesia. Postoperative atelectasis was described in the last century. It is defined as the closure of the alveoli due to a decrease in inspiratory force and collapse of the lung and the resulting loss of aeration.
Inhalation anaesthetics have been shown to cause hypoxic pulmonary vasoconstriction in studies. However, not all inhalation anaesthetics affect the airways in the same way.
In patients who will undergo surgical procedures under different general anaesthesia maintenance methods, conditions that disrupt the ventilation-perfusion balance in the lung peroperatively can be diagnosed and monitored early, easily and inexpensively by lung ultrasonography.
Lung ultrasound is a noninvasive, reliable, reliable, radiation-free imaging method that provides instantaneous imaging at the bedside. Lung ultrasound score is a scoring system that provides scoring of the loss of ventilation in the lung. For this purpose, it was aimed to divide both lung tissues into 12 areas and to give a score between 0 and 3 points and to show the severity of the loss of aeration according to the resulting total score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Total IV anesthesia | – | Procedure: LUNG ULTRASOUND |
| Group Sevoflurane | – | Procedure: LUNG ULTRASOUND |
| Group Desflurane | – | Procedure: LUNG ULTRASOUND |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 years old, ASA I-II, who will undergo rhinoplasty, septorhinoplasty operation
Key inclusion criteria (1 listed)
- 18-65 years old ASA I-II Surgical procedure time between 2 hours and 5 hours in supine position Patients who will undergo rhinoplasty, septorhinoplasty operation Patients whose consent was obtained with an informed consent form
Key exclusion criteria (12 listed)
- Those with a history of malignant hyperthermia,
- People with alcohol or drug addiction,
- Presence of dementia or confusion,
- Uncooperative patients,
- Those with respiratory disease,
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 |
|---|---|---|
| LUNG ULTRASOUNDDetermination of atelectsis By Lung Ultrasound Score | Procedure or surgery | Group Desflurane, Group Sevoflurane, Group Total IV anesthesia |
Primary outcome
Peroperative Atelectasis
Time frame: from induction to postoperative 1st hour
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 24 Jan 2025.
- Individual participant dataSharing planned: No
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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 Atelectasis and General Aneshesia, run by Zonguldak Bulent Ecevit 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 1 inclusion and 12 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 24 Jan 2025. 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.
What does the primary outcome measure?
Peroperative Atelectasis (time frame: from induction to postoperative 1st hour). 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 24 Jan 2025.