Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound

Assessment Clinical Trial

Official title:

Pulmonary Ultrasound to Evaluate Protective Lung Ventilation in Obese Patients With Postoperative Pulmonary Complications Impact

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991727
• Other study ID #: KYLL-2021-277
• Status: Recruiting
• Start date: August 21, 2021
• Est. completion date: December 23, 2023

Study information

• Verified date: July 2021
• Source: General Hospital of Ningxia Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Peri - operative ultrasonography was used to evaluate the effects of protective lung ventilation on the postoperative lungs of obese patients.The purpose of this study was to apply ultrasound lung ventilation area score to the monitoring of pulmonary complications in patients with postoperative obesity.To verify the reliability and practicability of perioperative lung ultrasound quantitative scoring.

Description:

Ultrasound lung ventilation area score was applied to monitor the pulmonary complications of patients after obesity operation to verify the perioperative period. The reliability and practicability of quantitative lung ultrasound score to clarify the effect of protective lung ventilation under perioperative pulmonary ultrasound monitoring on obesity patients.To guide the management of mechanical ventilation under general anesthesia and the prevention and treatment of postoperative pulmonary complications

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• enrollment of patients aged 18 years or above;
• Eligible adult patients had an American Society of Anesthesiologists (ASA) physical status classification of I to IV
• undergoing elective or expedited nonurgent, noncardiac surgery with general anesthesia

Exclusion Criteria:

• patient refusal;
• morbid obesity (BMI >40 kg/ m²);
• American Society of Anesthesiologists (ASA) physical status categories IV-V;
• previous intrathoracic procedure;
• severechronic obstructive pulmonary disease (forced expiratory volume in 1 s <30% of the predicted value;
• a contraindication to radial artery cannulation.

Related Conditions & MeSH terms

• Assessment

Intervention

Behavioral:
• recruitment maneuvers
Immediately after endotracheal intubation is completed First RM (pulmonary retraction), maintain pressure at 40cmH2O for 30s, and then Mechanical ventilation was maintained with 7cmH2O PEEP, and the RMS was repeated every 30 minutes until the end of surgery

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Costamagna A, Pivetta E, Goffi A, Steinberg I, Arina P, Mazzeo AT, Del Sorbo L, Veglia S, Davini O, Brazzi L, Ranieri VM, Fanelli V. Clinical performance of lung ultrasound in predicting ARDS morphology. Ann Intensive Care. 2021 Mar 29;11(1):51. doi: 10.1186/s13613-021-00837-1. — View Citation

Wangüemert Pérez AL. Clinical applications of pulmonary ultrasound. Med Clin (Barc). 2020 Apr 10;154(7):260-268. doi: 10.1016/j.medcli.2019.11.001. Epub 2020 Jan 8. Review. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung ultrasound scoring	Four signs were used in lung ultrasound scoring; Lung ultrasound score: N (0): pleural line and A line, less than 3 B lines; B1 (1 mark): More than 3; B line; B2 (2 points): Fuse line B; C (3 points): Signs of lung consolidation. The higher the score is, the worse the pulmonary ventilation status is.; When scoring, the sign with the greatest severity is taken as the score value of the examination area. There are 12 examination areas in both lungs, so we have a LUS; The score is between 0 and 36	in the morning of the first day
Secondary	Results of arterial blood gas analysis	PCO2	entering the operating room, in the morning of the first day ,the second day , the third day after surgery
Secondary	Mechanical ventilation parameter	peak inspiratory pressure	entering the operating room, in the morning of the first day ,the second day , the third day after surgery