Back to resultsOpen Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery
Primary Purpose
Abdominal Surgery, Obese Patients
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ARM
spontanous ventilation
Sponsored by
About this trial
This is an interventional health services research trial for Abdominal Surgery focused on measuring Open lung approach, conventional ventilation
Eligibility Criteria
Inclusion Criteria:
- Patient aged between 18 - 65 years
- BMI between 30-40 kg/m²
- ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery
Exclusion Criteria:
- Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 < 80% of the predicted value)
- active asthma, acute respiratory distress syndrome
- history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
- significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension
Sites / Locations
- Faculty of Medicine,Zagazig University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SPV spontanous ventilation
OLA open lung ventilation
Arm Description
The patients will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
The patients will undergo ARM followed by personalized PEEP.
Outcomes
Primary Outcome Measures
post-operative pulmonary complications
Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.
Secondary Outcome Measures
heart rate
hemodynamic changes
airway pressure
During mechanical ventilation airway pressures will be continuously monitored.
pulmonary complications.
1. Postoperative pulmonary complications which are defined as having one or more of the following: 1.Pneumonia 2. Respiratory failure requiring mechanical ventilation (Postoperative PaO2 < 60 mm Hg on room air, a PaO2:FiO2 ratio < 300 mm Hg) or peripheral oxygen saturation (SpO₂) <90% and requiring oxygen therapy ). 3. Atelectasis requiring bronchoscopic intervention 4. Pulmonary edema ( postoperative acute lung injury or ARDS). 5. Delayed tracheal extubation ( >24 hours postoperatively) or need for reintubation (because of respiratory distress, hypoxia, hypercarbia, or respiratory acidosis). 6. Pneumothorax 7. Bronchospasm (Newly detected refractory expiratory wheeze requiring bronchodilators
length of hospital stay,
the length of hospital stay, and 30 days mortality.
mean arterial blood pressure
hemodynamic changes
ETCO2
hemodynamic changes
tidal volume
During mechanical ventilation tidal volume will be continuously monitored.
SpO2
hemodynamic changes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04506736
Brief Title
Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery
Official Title
Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the purpose of this study is to compare open lung approach versus conventional protective ventilation in obese patients undergoing open abdominal surgery
Detailed Description
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 24 patients Group SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Group OLA: The patients will undergo ARM followed by personalized PEEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Surgery, Obese Patients
Keywords
Open lung approach, conventional ventilation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participant, Care Provider
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPV spontanous ventilation
Arm Type
Active Comparator
Arm Description
The patients will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Arm Title
OLA open lung ventilation
Arm Type
Active Comparator
Arm Description
The patients will undergo ARM followed by personalized PEEP.
Intervention Type
Other
Intervention Name(s)
ARM
Other Intervention Name(s)
followed by personalized PEEP.
Intervention Description
The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O.
The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.
Intervention Type
Other
Intervention Name(s)
spontanous ventilation
Intervention Description
volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
Primary Outcome Measure Information:
Title
post-operative pulmonary complications
Description
Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.
Time Frame
one week postoperative
Secondary Outcome Measure Information:
Title
heart rate
Description
hemodynamic changes
Time Frame
Baseline (before surgery) and intraoperative
Title
airway pressure
Description
During mechanical ventilation airway pressures will be continuously monitored.
Time Frame
intraoperative
Title
pulmonary complications.
Description
1. Postoperative pulmonary complications which are defined as having one or more of the following: 1.Pneumonia 2. Respiratory failure requiring mechanical ventilation (Postoperative PaO2 < 60 mm Hg on room air, a PaO2:FiO2 ratio < 300 mm Hg) or peripheral oxygen saturation (SpO₂) <90% and requiring oxygen therapy ). 3. Atelectasis requiring bronchoscopic intervention 4. Pulmonary edema ( postoperative acute lung injury or ARDS). 5. Delayed tracheal extubation ( >24 hours postoperatively) or need for reintubation (because of respiratory distress, hypoxia, hypercarbia, or respiratory acidosis). 6. Pneumothorax 7. Bronchospasm (Newly detected refractory expiratory wheeze requiring bronchodilators
Time Frame
one week postoperative
Title
length of hospital stay,
Description
the length of hospital stay, and 30 days mortality.
Time Frame
postoperative up to one month
Title
mean arterial blood pressure
Description
hemodynamic changes
Time Frame
Baseline (before surgery) and intraoperative
Title
ETCO2
Description
hemodynamic changes
Time Frame
Baseline (before surgery) and intraoperative
Title
tidal volume
Description
During mechanical ventilation tidal volume will be continuously monitored.
Time Frame
intraoperative
Title
SpO2
Description
hemodynamic changes
Time Frame
Baseline (before surgery) and intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged between 18 - 65 years
BMI between 30-40 kg/m²
ASA I and II,open elective abdominal surgery which is expected to last for more than 2 hours under general anesthesia and planned to be extubated at the end of surgery
Exclusion Criteria:
Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 < 80% of the predicted value)
active asthma, acute respiratory distress syndrome
history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic heart disease, heart failure
significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal diseases ischemic heart disease, heart failure, significant arrhythmias and intracranial hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howida A kamal, M.D
Organizational Affiliation
zagazig U
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine,Zagazig University
City
Zagazig
State/Province
Zagazig, Elsharkia,egypt
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
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Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery
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