Clinical trial NCT05502926: Use of Point-of-care Lung Ultrasound Before and After Surgery Trying to Predict Post-operative Pulmonary Complications
Official title: Perioperative Lung Ultrasound Score (LUS) for Prediction of Postoperative Pulmonary Complications (PPC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Postoperative Complications
Anesthesia
Surgery-Complications
Pulmonary Complication
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presented for elective intra-abdominal surgery

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.

Eligibility criteria: 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.

Primary outcomes:
measure: post operative oxygen treatment
timeFrame: 48 hours
measure: icu admission / reintubation
timeFrame: during hospital stay
measure: postoperative pneumonia
timeFrame: 48 hours
measure: death
timeFrame: 48 hours
Secondary outcomes:
measure: PACU stay
timeFrame: during hospital stay
measure: PACU oxygen therapy
timeFrame: during hospital stay
measure: PACU discharge oxygen therapy
timeFrame: during hospital stay
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: evgeni brotfaine, prof
role: STUDY_DIRECTOR
References: