Use of Point-of-care Lung Ultrasound Before and After Surgery Trying to Predict Post-operative Pulmonary Complications

NCT ID: NCT05502926

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-09-01

Brief Summary

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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

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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

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Ultrasonography Postoperative Complications Anesthesia Surgery-Complications Pulmonary Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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lung ultrasound score

peroperative and postoperative 12 point trans-thoracic lung ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Moshe Rucham MD

OTHER

Sponsor Role lead

Responsible Party

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Moshe Rucham MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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evgeni brotfaine, prof

Role: STUDY_DIRECTOR

Soroka University Medical Center

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 39685557 (View on PubMed)

Other Identifiers

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SOR001022CTIL

Identifier Type: -

Identifier Source: org_study_id

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