Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06181279

Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study

Led by Yongtao Sun · Updated on 2024-06-04

52

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the impact of individualized positive end-expiratory pressure (PEEP) guided by driving pressure on reducing postoperative pulmonary atelectasis in patients with morbid obesity undergoing bariatric surgery. Atelectasis is a common complication after surgery under general anesthesia, particularly in obese patients, and can lead to further issues like low oxygen levels and pneumonia. This study is a single-center, randomized controlled trial aiming to assess a novel lung protection strategy during surgery. Participants will be randomly assigned to one of two groups. In the individualized PEEP group, after a recruitment maneuver, PEEP is adjusted downwards based on driving pressure measurements to find the optimal PEEP that minimizes lung pressure, repeated three times at specific surgery stages. The fixed PEEP group receives a constant PEEP of 8 cmH2O after the same maneuver. This approach aims to compare the effectiveness of personalized lung ventilation against a standard fixed setting. During the study, measurements will be taken 30 minutes after extubation to evaluate the incidence of postoperative pulmonary atelectasis and lung ultrasound scores. Patients will be monitored throughout surgery and postoperatively to assess lung function and complications. The total participation includes surgery and immediate postoperative evaluations, with safety and lung protection outcomes carefully recorded to determine the benefit of the individualized ventilation strategy.

CONDITIONS

Brief Title

Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years old
  • Body mass index (BMI) 65 40 kg/m2
  • ASA classification I to III
  • Signing the informed consent form for this clinical study
Not Eligible

You will not qualify if you...

  • Respiratory infection within 4 weeks
  • Severe respiratory system diseases
  • History of pulmonary and/or thoracic surgery
  • Neuromuscular dysfunction
  • Serious cardiac, renal or haematopoietic diseases
  • Contraindications to PEEP

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Surgery day

Participants undergo bariatric surgery with ventilation strategies involving individualized or fixed positive end-expiratory pressure (PEEP) guided by driving pressure during the operation.

1 surgery day visit (in-person)

Post-operative Follow-up

Duration - 30 minutes after extubation

Participants are assessed for postoperative pulmonary atelectasis and pulmonary ultrasound scores after surgery.

1 post-operative visit (in-person)

Trial Site Locations

Total: 1 location

1

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Jinan, Shandong, China, 250014

Actively Recruiting

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Research Team

Y

yong t Sun, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effect of driving pressure-guided individualised positive end-expiratory pressure on postoperative atelectasis in patients with morbid obesity: study protocol of a randomised controlled trial.

Yawen Ren, Yong T Sun, Peipei Zhang...

https://pubmed.ncbi.nlm.nih.gov/40050061