Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound

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

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.

Study Overview

• Status: Recruiting
• Conditions: Assessment
• Intervention / Treatment: Behavioral: recruitment maneuvers

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • General Hospital of Ningxia Medical University
      • Contact: Ma Hanxiang; Phone Number: +86-13519591508; Email: mahanxiang@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgery, non-cardiac surgery, in the Heart and Brain Hospital of Ningxia Medical University from June, 2021 to October, 2023

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEEP; The patient was admitted to the operating room, and routine ECG monitoring was performed. The patient was placed in supine position, and ultrasound lung examination was performed. The images of the patient were saved and the score of lung ventilation area was recorded. The induction of general anesthesia was started, and endotracheal intubation was performed after 3min of preoxygenation (100% O2) to establish a safe and effective artificial airway.Mechanical ventilation was performed after endotracheal intubation, and a second time was performed immediately after endotracheal intubation was completed.Pulmonary ultrasound was performed. The PEEPgroup was given the first RM (pulmonary retraction) with pressure maintained at 40cmH2O for 30s, followed by a 7cmH2O PEEP to maintain mechanical ventilation, and the RMS was repeated every 30 minutes until the end of surgery	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
ZEEP; The patient was admitted to the operating room, and routine ECG monitoring was performed. The patient was placed in supine position, and ultrasound lung examination was performed. The images of the patient were saved and the score of lung ventilation area was recorded. The induction of general anesthesia was started, and endotracheal intubation was performed after 3min of preoxygenation (100% O2) to establish a safe and effective artificial airway. Mechanical ventilation was performed after endotracheal intubation, and a second time was performed immediately after endotracheal intubation was completed On pulmonary ultrasound, patients in the ZEEP group maintained normal mechanical ventilation throughout the operation without PEEP or RMS	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Publications and helpful links

General Publications

• Wanguemert Perez 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. English, Spanish.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 21, 2021
• Primary Completion (Anticipated): October 23, 2023
• Study Completion (Anticipated): December 23, 2023

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; lung ultrasound; Protective pulmonary ventilation
• Other Study ID Numbers: KYLL-2021-277

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No