Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04258202
Other study ID # SMC2019-11-117-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2, 2020
Est. completion date October 8, 2020

Study information

Verified date January 2020
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung volume but it remains unknown which method is most effective. The primary aim was to compare the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20 cmH20).


Description:

General anesthesia promotes the formation of atelectasis, which negatively impacts respiratory function and may be associated with subsequent pulmonary complications. Especially, during laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics, suggesting that performing an Alveolar recruitment maneuvers after intubation, circuit disconnection, position change, intraabdominal gas infiltration. Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on the anaesthesia machine with the adjustable pressure-limiting valve set to the desired inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when switching back to the ventilator circuit, which results in re-collapse of alveoli. For this reason, investigators try to compare the methods of the ventilator-driven ARM.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 8, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - patients who receive laparoscopic surgery in trendelenberg position Exclusion Criteria: - Patients who are simultaneously participating in other studies - Patients who are scheduled to leave the intensive care unit after surgery - Patients with obstructive or restrictive pattern of Severe or moderate grade on Pulmonary function test - High risk in cardiovascular events (expected postoperative cardiovascular event > 5%) - Patients with emphysema confirmed by imaging test - patients with obesity BMI > 35 kg / m2

Study Design


Intervention

Other:
Alveolar recruitment maneuver
The two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O.

Locations

Country Name City State
Korea, Republic of Samsung medical center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the change of Atelectasis volume electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%) intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary the change of lung compliance value comparison of lung compliance mL/cmH2O (static compliance=tidal volume/driving pressure) before/after recruitment maneuver intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary the change of arterial blood gas analysis comparison of PaO2/fraction of inspired oxygen (FiO2) mmHg before/after recruitment maneuver intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary the change of driving pressure value comparison of driving pressure cmH2O (plateau pressure-positive end expiratory pressure) before/after recruitment maneuver intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary the change of peak pressure value comparison peak pressure (cmH2O) before/after recruitment maneuver intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
Secondary The difference of atelectasis atelectasis score by lung ultrasonography (score range 0~36) at postoperative 30 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT06021249 - Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients N/A
Terminated NCT03581474 - Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting N/A
Completed NCT02871258 - MetaNeb® Chest X-ray Study N/A
Completed NCT02523755 - Evaluation of Regional Distribution of Ventilation During Labor With or Without Epidural Analgesia Phase 4
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Completed NCT02216006 - High Fresh Gas Flow After Intubation N/A
Completed NCT01416519 - Physiotherapy Technique Decreases Respiratory Complications After Cardiac Operation N/A
Completed NCT03153592 - Effects of Mechanical Ventilation Guided by Transpulmonary Pressure on Gas Exchange During Robotic Surgery: a Pilot Study N/A
Completed NCT03694665 - Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese N/A
Completed NCT04506203 - The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool N/A
Not yet recruiting NCT06296173 - Open Lung Protective Extubation Following General Anesthesia N/A
Completed NCT04006665 - Role of Lung Ultrasonography in Diagnosing Atelectasis in Robotic Pelvic Surgeries
Completed NCT03614845 - Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery N/A
Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Completed NCT01993394 - Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion N/A
Completed NCT00671723 - Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients N/A
Completed NCT03378752 - Atelectasis Formation Using HFJV During Stereotactic Solid Organ Ablations
Completed NCT05963945 - Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Completed NCT03592589 - Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia in Children N/A
Completed NCT04458623 - Air Test In Diagnosis Of Postoperative Lung Atelectasis N/A