Postoperative Pulmonary AtelectasisNCT02355405
Diagnostic Values of Lung Ultrasound for Perioperative Atelectasis
An observational study of Postoperative Pulmonary Atelectasis, run by The Third Xiangya Hospital of Central South University at 2 sites in China.
Trial summary
Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative atelectasis and evaluating its severity in adult patients undergoing general anesthesia in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Atelectasis
- What is being tested?
- lung ultrasound and thoracic computed tomography
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 46 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2015to Apr 2015
- 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: Patients undergoing selective neurosurgical operation in Xiangya Hospital or The Third Xiangya Hospital of Central South University
Who may be able to join
- Aged 18 years and older;
- American Society of Anesthesiologists (ASA) physical status within class I-III;
- Scheduled for selective neurosurgical operation with general anesthesia;
- Need of mechanical ventilation more than 2 hours;
Who cannot join
- Patients decline to participate;
- Pregnancy;
- Previous thoracic procedures (thoracic drain, thoracotomy, thoracoscopy);
- A history of pulmonary diseases within last two weeks with abnormal manifestation of lung CT (pulmonary parenchyma or/and interstitial lesions );
- Pneumothorax or subcutaneous emphysema during peri-operation;
- Patients with a body mass index (BMI) more than 30 kg/m2;
- Emergency operation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Diagnostic Performance of Lung Ultrasound for Perioperative Atelectasis in Adult Patients Undergoing General Anesthesia
Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative atelectasis and evaluating its severity in adult patients undergoing general anesthesia in the operating room.
Read the detailed description
Atelectases occur in up to 90% of patients undergoing general anesthesia and intubation. The aim of the present observational study was designed to further to evaluate the diagnostic performance of lung ultrasound (LUS) in detection of postoperative atelectasis in adult patients undergoing general anesthesia. Results of LUS as the experimental method will be compared to the results of computed tomography (CT) as the reference technique for the detection of atelectasis. The investigators want to confirm former findings of the appearance of perioperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.
- Conditions
- Postoperative Pulmonary Atelectasis
- Being tested
- lung ultrasound, thoracic computed tomography
- Keywords
- lung ultrasound, atelectasis, thoracic computed Tomography
- 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 ultrasoundDevice
lung ultrasound investigations were performed right before and after the surgical procedure.
thoracic computed tomographyRadiation
thoracic CT were performed within one hour after the LUS investigation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between manifestations of atelectasis in lung ultrasound and in thoracic computed tomography.
Measurements of lung ultrasound are performed before induction of anesthesia and immediately after finishing the surgery. Lung CTs are performed the day before surgery and within 1 hour after surgery. Outcome measure: comparison of atelectases by lung ultrasound (experimental method) versus by computed tomography (standard method)
Measured: From 5 minutes before induction of anesthesia to 1 hour after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary AtelectasisStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355405
- Sponsor's protocol ID
- XY3-LUS-8711
- Status last verified
- Apr 2015
- First submitted
- 30 Jan 2015
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Lung Ultrasound for Perioperative Atelectasis in Adult Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT02355405
- Acronym / sponsor ID
- XY3-LUS-8711
- Conditions
- Postoperative Pulmonary Atelectasis
- Keywords
- lung ultrasound, atelectasis, thoracic computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Feb 2015 (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.
Lung ultrasound offers a novel, reliable and radiation-free tool for diagnosing perioperative atelectasis and evaluating its severity in adult patients undergoing general anesthesia in the operating room.
Detailed description
Atelectases occur in up to 90% of patients undergoing general anesthesia and intubation. The aim of the present observational study was designed to further to evaluate the diagnostic performance of lung ultrasound (LUS) in detection of postoperative atelectasis in adult patients undergoing general anesthesia. Results of LUS as the experimental method will be compared to the results of computed tomography (CT) as the reference technique for the detection of atelectasis. The investigators want to confirm former findings of the appearance of perioperative atelectases and to prove that ultrasound is a valid tool for detection of atelectases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing selective neurosurgical operation in Xiangya Hospital or The Third Xiangya Hospital of Central South University
Key inclusion criteria (4 listed)
- Aged 18 years and older;
- American Society of Anesthesiologists (ASA) physical status within class I-III;
- Scheduled for selective neurosurgical operation with general anesthesia;
- Need of mechanical ventilation more than 2 hours;
Key exclusion criteria (7 listed)
- Patients decline to participate;
- Pregnancy;
- Previous thoracic procedures (thoracic drain, thoracotomy, thoracoscopy);
- A history of pulmonary diseases within last two weeks with abnormal manifestation of lung CT (pulmonary parenchyma or/and interstitial lesions );
- Pneumothorax or subcutaneous emphysema during peri-operation;
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 ultrasoundlung ultrasound investigations were performed right before and after the surgical procedure. | Device | – |
| thoracic computed tomographythoracic CT were performed within one hour after the LUS investigation | Radiation | – |
Primary outcome
Correlation between manifestations of atelectasis in lung ultrasound and in thoracic computed tomography.
Time frame: From 5 minutes before induction of anesthesia to 1 hour after the surgery
Measurements of lung ultrasound are performed before induction of anesthesia and immediately after finishing the surgery. Lung CTs are performed the day before surgery and within 1 hour after surgery. Outcome measure: comparison of atelectases by lung ultrasound (experimental method) versus by computed tomography (standard method)
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 21 Apr 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pulmonary Atelectasis, run by The Third Xiangya Hospital of Central South University at 2 sites in China.
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: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Correlation between manifestations of atelectasis in lung ultrasound and in thoracic computed tomography. (time frame: From 5 minutes before induction of anesthesia to 1 hour after the surgery). 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 21 Apr 2015.