Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04728945
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Toho University School of Medicine
Information provided by (Responsible Party):
Osaka University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.

Condition or disease Intervention/treatment Phase
Perioperative Complication Hypoxia Procedure: lung recruitment Procedure: Standard ventilatory management Not Applicable

Detailed Description:
The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
Actual Study Start Date : June 18, 2021
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: lung recruitment
Standard ventilatory management with lung recruitment every 30 minutes
 Procedure: lung recruitment
Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.

Procedure: Standard ventilatory management

After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary.

[initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)
Active Comparator: control
Standard ventilatory management
 Procedure: Standard ventilatory management

After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary.

[initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of hypoxia [ Time Frame: During laparoscopy procedure ]
    SpO2 less than 95% or more than 2% decrease from baseline

  2. Time to onset of hypoxia [ Time Frame: During laparoscopy procedure ]
    Duration from the start of laparoscopic surgery to the onset of hypoxia


Secondary Outcome Measures :
  1. Rate of decrease in SpO2 [ Time Frame: During laparoscopy procedure ]
    Difference between baseline SpO2 and minimum SpO2 during laparoscopic surgery

  2. Ventilator setting at the end of surgery [ Time Frame: During surgery ]
    Ventilator settings such as FIO2, PEEP, and plateau pressure

  3. compliance rate of lung recruitment [ Time Frame: During laparoscopy procedure ]
    compliance rate of lung recruitment in the intevention group

  4. Safety endpoint: Circulatory agonist use [ Time Frame: During surgery ]
    Circulatory agonist use

  5. Safety endpoint: total fluid infusion [ Time Frame: During surgery ]
    total fluid infusion

  6. Safety endpoint: incidence of complications [ Time Frame: During surgery ]
    incidence of complications (hypotension, arrhythmia, pneumothorax, atelectasis defined by the blinded investigator)

  7. Postoperative hypoxia [ Time Frame: the day after surgery ]
    Presence of hypoxia the day after surgery


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours

Exclusion Criteria:

  • Lateral or supine position
  • BMI > 35
  • One-second rate <70%, %VC <80%, obstructive, restrictive, with bra
  • Cardiovascular disease (NYHA III or higher)
  • Intracranial hypertensive disease
  • Emergency surgery
  • Pregnancy
  • Glaucoma
  • Patients judged unsuitable by the anesthesiologist in charge
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728945


Contacts
Layout table for location contacts
Contact: Yuji Fujino, MD., Ph.D. +81-6-6879-5820 fujino@anes.med.osaka-u.ac.jp

Locations
Layout table for location information
Japan
Department of Anesthesiology and Intensive Care Medicine, Osaka University Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Yuji Fujino, MD., Ph.D.    +81-6-6879-5820    fujino@anes.med.osaka-u.ac.jp   
Sponsors and Collaborators
Osaka University
Toho University School of Medicine
Investigators
Layout table for investigator information
Study Chair: Yuji Fujino Department of Anesthesiology and Intensive Care Medicine, Osaka University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Osaka University
ClinicalTrials.gov Identifier: NCT04728945    
Other Study ID Numbers: Reclap study
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osaka University:
perioperative pulmonary complications
lung recruitment
laparoscopic surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoxia
Signs and Symptoms, Respiratory