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

Anesthesia Clinical Trial

Official title:

Perioperative Lung Ultrasound Score (LUS) for Prediction of Postoperative Pulmonary Complications (PPC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05502926
• Other study ID #: SOR001022CTIL
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2024
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Postoperative Complications
• Pulmonary Complication
• Ultrasonography

Intervention

Diagnostic Test:
• lung ultrasound score
peroperative and postoperative 12 point trans-thoracic lung ultrasound

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Moshe Rucham MD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	icu admission / reintubation	unplanned postoperative admission to icu or re-intubation	during hospital stay
Primary	postoperative pneumonia	clinical or radiographic diagnosis of pneumonia	48 hours
Primary	death	postoperative death of any cause	48 hours
Secondary	PACU stay	total length of stay at the post operative care unit	during hospital stay
Secondary	PACU oxygen therapy	total time with oxygen treatment (nasal cannula, face mask) in the post operative care unit	during hospital stay
Secondary	PACU discharge oxygen therapy	oxygen treatment (nasal cannula, face mask) on discharge from the post operative care unit	during hospital stay