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OpenTrials
Completed

NCT Number: NCT05502926

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soroka Medical Center

Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Ultrasound Score

Diagnostic Test

peroperative and postoperative 12 point trans-thoracic lung ultrasound

Primary outcomes

  1. post operative oxygen treatment

    Time frame: 48 hours

    any kind of oxygen therapy (face mask, nasal cannula, CPAP/BIPAP) more then 12 hours after and of surgery, or desaturation <90%

  2. icu admission / reintubation

    Time frame: during hospital stay

    unplanned postoperative admission to icu or re-intubation

  3. postoperative pneumonia

    Time frame: 48 hours

    clinical or radiographic diagnosis of pneumonia

  4. death

    Time frame: 48 hours

    postoperative death of any cause

Secondary outcomes

  1. PACU stay

    Time frame: during hospital stay

    total length of stay at the post operative care unit

  2. PACU oxygen therapy

    Time frame: during hospital stay

    total time with oxygen treatment (nasal cannula, face mask) in the post operative care unit

  3. PACU discharge oxygen therapy

    Time frame: during hospital stay

    oxygen treatment (nasal cannula, face mask) on discharge from the post operative care unit

Sponsors and collaborators

Lead sponsor

Moshe Rucham MD

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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