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

Completed

• Conditions: Postoperative Complications; Anesthesia; Pulmonary Complication; Surgery-Complications; Ultrasonography

• Registration Number: NCT05502926
• Lead Sponsor: Moshe Rucham MD

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

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-14
• Study First Posted: 2022-08-16
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-16
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post operative oxygen treatment	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	during hospital stay	unplanned postoperative admission to icu or re-intubation
death	48 hours	postoperative death of any cause
postoperative pneumonia	48 hours	clinical or radiographic diagnosis of pneumonia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel