Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound

NCT04991727 | Unknown

• 1 other identifier: KYLL-2021-277
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Assessment

Keywords

lung ultrasound; Protective pulmonary ventilation; Postoperative pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Results of arterial blood gas analysis

  entering the operating room, in the morning of the first day ,the second day , the third day after surgery

• Mechanical ventilation parameter

  entering the operating room, in the morning of the first day ,the second day , the third day after surgery

Study Arms (2)

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

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

Interventions

recruitment maneuvers BEHAVIORAL

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

PEEP; ZEEP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 31926654 BACKGROUND

• 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.

  PMID: 33779834 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: August 5, 2021
• Study Start: August 21, 2021
• Primary Completion: October 23, 2023
• Study Completion: December 23, 2023
• Last Updated: August 5, 2021

Record last verified: 2021-07

Locations

CN (1)