Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound

• Conditions: Assessment
• Interventions: Behavioral: recruitment maneuvers

• Registration Number: NCT04991727
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

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 Timeline

• Study First Submitted: 2021-06-26
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Study Start: 2021-08-21
• Primary Completion: 2023-10-23
• Study Completion: 2023-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ZEEP	recruitment maneuvers	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
PEEP	recruitment maneuvers	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

Primary Outcome Measures

Name	Time	Method
Lung ultrasound scoring	in the morning of the first day	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

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation parameter	entering the operating room, in the morning of the first day ,the second day , the third day after surgery	peak inspiratory pressure
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	PCO2

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China