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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Ultrasonography; Anesthesia; Pulmonary Complication; Surgery-Complications
• Intervention / Treatment: Diagnostic test: lung ultrasound score

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 Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Soroka Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients presented for elective intra-abdominal surgery

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	48 hours
icu admission / reintubation	unplanned postoperative admission to icu or re-intubation	during hospital stay
postoperative pneumonia	clinical or radiographic diagnosis of pneumonia	48 hours
death	postoperative death of any cause	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU stay	total length of stay at the post operative care unit	during hospital stay
PACU oxygen therapy	total time with oxygen treatment (nasal cannula, face mask) in the post operative care unit	during hospital stay
PACU discharge oxygen therapy	oxygen treatment (nasal cannula, face mask) on discharge from the post operative care unit	during hospital stay

Collaborators and Investigators

• Sponsor: Moshe Rucham MD
• Investigators: Study Director: evgeni brotfaine, prof, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: SOR001022CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: this is a preliminary study in this subject

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No