Evaluation of Protective Pulmonary Ventilation by Pulmonary Ultrasound

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04991727
Collaborator
(none)
100
1
28.1
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pulmonary Ultrasound to Evaluate Protective Lung Ventilation in Obese Patients With Postoperative Pulmonary Complications Impact
Anticipated Study Start Date :
Aug 21, 2021
Anticipated Primary Completion Date :
Oct 23, 2023
Anticipated Study Completion Date :
Dec 23, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004

Sponsors and Collaborators

  • General Hospital of Ningxia Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier:
NCT04991727
Other Study ID Numbers:
  • KYLL-2021-277
First Posted:
Aug 5, 2021
Last Update Posted:
Aug 5, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by General Hospital of Ningxia Medical University

Study Results

No Results Posted as of Aug 5, 2021