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

NCT05502926 | Completed

• 1 other identifier: SOR001022CTIL
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ultrasonography; Postoperative Complications; Anesthesia; Surgery-Complications; Pulmonary Complication

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• PACU stay

  during hospital stay

• PACU oxygen therapy

  during hospital stay

• PACU discharge oxygen therapy

  during hospital stay

Interventions

lung ultrasound score DIAGNOSTIC_TEST

peroperative and postoperative 12 point trans-thoracic lung ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients presented for elective intra-abdominal surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Moshe Rucham MD: lead

Study Sites (1)

Soroka Medical Center

Beersheba, Israel

Location

Related Publications (1)

• 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.

  PMID: 39685557 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• evgeni brotfaine, prof

  Soroka University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 16, 2022
• Study Start: April 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

IL (1)