UltrasonographyNCT05502926
Use of Point-of-care Lung Ultrasound Before and After Surgery Trying to Predict Post-operative Pulmonary Complications
An observational study of Ultrasonography and Postoperative Complications, run by Moshe Rucham MD at 1 site in Israel.
Trial summary
Patients undergoing surgery inside their abdomen, with no serious heart or lung diseases, will have a lung ultrasound exam before and after surgery. The patient respiratory status in the post-operative unit and the surgical ward will be monitored for complications after surgery Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Postoperative Complications, Anesthesia
- What is being tested?
- lung ultrasound score
- How many people
- 163 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2022to 1 Sep 2023
- How long will I take part?
- 10 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients presented for elective intra-abdominal surgery
Who may be able to join
- The population study will include patients 18 years and older, with ASA class I, II or III, presenting for elective intra-abdominal surgery under general anesthesia and are not planned for long-term post-surgical mechanical ventilation.
Who cannot join
- Patient will be excluded from the study if they have pre-existing moderate or severe heart or lung disease: a history of ischemic heart disease, moderate or severe systolic or diastolic heart failure, moderate or severe pulmonary hypertension, moderate or severe obstructive or interstitial lung disease. Patients will also be excluded if they had a severe intra-operative pulmonary complication (laryngospasm, bronchospasm, anaphylaxis, emergency surgical airway). Patients who require un-planned long term mechanical ventilation or those who died during surgery will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Lung Ultrasound Score (LUS) for Prediction of Postoperative Pulmonary Complications (PPC)
Patients undergoing surgery inside their abdomen, with no serious heart or lung diseases, will have a lung ultrasound exam before and after surgery. The patient respiratory status in the post-operative unit and the surgical ward will be monitored for complications after surgery
Read the detailed description
The study will be performed in the Soroka hospital operating room and recovery unit.
On admission to pre-surgery, patients will be investigates for inclusion and exclusion criteria. Those that are eligible for the study will be asked to give formal consent to participate in the study. After consent the examiner will review the patient's past medical history and surgery plan, and will preform the pre-operative LUS exam.
After surgery, the examiner will review the electronic anesthesia record and will preform the post-operative LUS exam within 30 minutes of arrival to the recovery unit or 30 minutes from extubation (in patients that were admitted to the recovery unit still under mechanical ventilation). Upon discharge from the recovery unit the examiner will review the recovery unit electronic record.
After discharge, the examiner will review the patient post-operative surgical ward electronic record.
- Conditions
- Ultrasonography, Postoperative Complications, Anesthesia, Surgery-Complications, Pulmonary Complication
- Being tested
- lung ultrasound score
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound scoreDiagnostic test
peroperative and postoperative 12 point trans-thoracic lung ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative oxygen treatment
any kind of oxygen therapy (face mask, nasal cannula, CPAP/BIPAP) more then 12 hours after and of surgery, or desaturation <90%
Measured: 48 hours
icu admission / reintubation
unplanned postoperative admission to icu or re-intubation
Measured: during hospital stay
postoperative pneumonia
clinical or radiographic diagnosis of pneumonia
Measured: 48 hours
death
postoperative death of any cause
Measured: 48 hours
Secondary outcomes (3)
PACU stay
total length of stay at the post operative care unit
Measured: during hospital stay
PACU oxygen therapy
total time with oxygen treatment (nasal cannula, face mask) in the post operative care unit
Measured: during hospital stay
PACU discharge oxygen therapy
oxygen treatment (nasal cannula, face mask) on discharge from the post operative care unit
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Apr 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasonographyStudies 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
- 163 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Moshe Rucham MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moshe Rucham MD, Soroka University Medical Center
- Investigators
- evgeni brotfaine, prof, Study director, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502926
- Sponsor's protocol ID
- SOR001022CTIL
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2022
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: this is a preliminary study in this subject
Publications
Rucham M, Lior Y, Fuchs L, Gruenbaum BF, Acker A, Zlotnik A, Brotfain E. Perioperative Lung Ultrasound Findings in Elective Intra-Abdominal Surgery: Associations with Postoperative Pulmonary Complications. J Clin Med. 2024 Nov 24;13(23):7098. doi: 10.3390/jcm13237098.
PubMed 39685557
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Lung Ultrasound Score (LUS) for Prediction of Postoperative Pulmonary Complications (PPC)
- ClinicalTrials.gov ID
- NCT05502926
- Acronym / sponsor ID
- SOR001022CTIL
- Conditions
- Ultrasonography, Postoperative Complications, Anesthesia, Surgery-Complications, Pulmonary Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Moshe Rucham MDUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 16 Aug 2022 (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.
Patients undergoing surgery inside their abdomen, with no serious heart or lung diseases, will have a lung ultrasound exam before and after surgery. The patient respiratory status in the post-operative unit and the surgical ward will be monitored for complications after surgery
Detailed description
The study will be performed in the Soroka hospital operating room and recovery unit.
On admission to pre-surgery, patients will be investigates for inclusion and exclusion criteria. Those that are eligible for the study will be asked to give formal consent to participate in the study. After consent the examiner will review the patient's past medical history and surgery plan, and will preform the pre-operative LUS exam.
After surgery, the examiner will review the electronic anesthesia record and will preform the post-operative LUS exam within 30 minutes of arrival to the recovery unit or 30 minutes from extubation (in patients that were admitted to the recovery unit still under mechanical ventilation). Upon discharge from the recovery unit the examiner will review the recovery unit electronic record.
After discharge, the examiner will review the patient post-operative surgical ward electronic record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients presented for elective intra-abdominal surgery
Key inclusion criteria (1 listed)
- The population study will include patients 18 years and older, with ASA class I, II or III, presenting for elective intra-abdominal surgery under general anesthesia and are not planned for long-term post-surgical mechanical ventilation.
Key exclusion criteria (1 listed)
- Patient will be excluded from the study if they have pre-existing moderate or severe heart or lung disease: a history of ischemic heart disease, moderate or severe systolic or diastolic heart failure, moderate or severe pulmonary hypertension, moderate or severe obstructive or interstitial lung disease. Patients will also be excluded if they had a severe intra-operative pulmonary complication (laryngospasm, bronchospasm, anaphylaxis, emergency surgical airway). Patients who require un-planned long term mechanical ventilation or those who died during surgery will also be excluded.
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 ultrasound scoreperoperative and postoperative 12 point trans-thoracic lung ultrasound | Diagnostic test | – |
Primary outcome
post operative oxygen treatment
Time frame: 48 hours
any kind of oxygen therapy (face mask, nasal cannula, CPAP/BIPAP) more then 12 hours after and of surgery, or desaturation <90%
icu admission / reintubation
Time frame: during hospital stay
unplanned postoperative admission to icu or re-intubation
postoperative pneumonia
Time frame: 48 hours
clinical or radiographic diagnosis of pneumonia
death
Time frame: 48 hours
postoperative death of any cause
3 secondary outcomes
PACU stay
Time frame: during hospital stay
PACU oxygen therapy
Time frame: during hospital stay
PACU discharge oxygen therapy
Time frame: during hospital stay
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 19 Mar 2024.
- Derived from this study: PubMed 39685557Rucham M, Lior Y, Fuchs L, Gruenbaum BF, Acker A, Zlotnik A, Brotfain E. Perioperative Lung Ultrasound Findings in Elective Intra-Abdominal Surgery: Associations with Postoperative Pulmonary Complications. J Clin Med. 2024 Nov 24;13(23):7098. doi: 10.3390/jcm13237098.
- Individual participant dataSharing planned: Undecided. this is a preliminary study in this subject
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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.
evgeni brotfaine, prof study director
Soroka University Medical Center
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 Ultrasonography and Postoperative Complications, run by Moshe Rucham MD at 1 site in Israel.
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 1 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 19 Mar 2024. 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 Israel. 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?
post operative oxygen treatment (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502926, which also lists 1 linked publication.
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 19 Mar 2024.