Back to resultsEffect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Inspiratory-to-expiratory (I : E) ratio of 1:2
Inspiratory-to-expiratory (I : E) ratio of 2:1
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring inverse ratio ventilation, safe apnea time
Eligibility Criteria
Inclusion Criteria:
- Obese patients, aged 18-65 years, of either gender, ASA grade II-III, body mass index (BMI) > 30 kg / m2, scheduled for general anesthesia under tracheal intubation, signed informed consent.
Exclusion Criteria:
- Patients who need rapid sequence induction (RSI); patients with expected difficult airway; severe chronic respiratory diseases, such as tuberculosis, bronchitis, bronchial asthma and COPD; patients with severe cardiovascular diseases, such as severe ischemic heart disease and pulmonary hypertension; patients with severe cerebrovascular diseases, such as cerebral hemorrhage and cerebral infarction; patients with abnormal basal metabolic rate, such as pregnancy, thyrotoxicosis, pheochromocytoma; and severe stomach reflux disease; patients with abnormal hemoglobin and hematocrit.
Sites / Locations
- General Hospital of Ningxia Medical University
- General Hospital of Ningxia Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1:2
Group 2:1
Arm Description
Patients in the control group had noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2.
Patients in the IRV group had noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1.
Outcomes
Primary Outcome Measures
Safe Apnea Time
The safe apnea time was defined as that period of time during which the arterial saturation as measured by pulse oximetry remained at or above 93% .
Secondary Outcome Measures
EtO2
Fractional concentration of oxygen in end-tidal gas
EtO2
Fractional concentration of oxygen in end-tidal gas
EtO2
Fractional concentration of oxygen in end-tidal gas
Full Information
NCT ID
NCT04627883
First Posted
October 11, 2020
Last Updated
November 8, 2020
Sponsor
General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04627883
Brief Title
Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients
Official Title
Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the clinical application value of inverse ratio ventilation in obese patients during induction of general anesthesia by studying the effect of inverse ratio ventilation on the safe apnea time.
Detailed Description
Inverse ratio ventilation(IRV) can produce mean airway pressure(Pmean)similar to external positive end expiratory pressure(Peep) by increasing inspiratory time. Moreover, the increase of Pmean was not accompanied by the further increase of peak airway pressure (Ppeak) and airway plateau pressure (Pplat), while the application of external peep accompanied with the increase of Pplat increased the risk of barotrauma . High level of Peep increased cardiac load and decreased cardiac output. A number of studies have found that the hemodynamic stability of patients can be achieved when IRV regulates the inspiratory / expiratory ratio in an appropriate range (I: E < 2:1). Therefore, the inverse ratio is considered to be superior to Peep in terms of gas exchange and respiratory mechanics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
inverse ratio ventilation, safe apnea time
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1:2
Arm Type
Other
Arm Description
Patients in the control group had noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2.
Arm Title
Group 2:1
Arm Type
Other
Arm Description
Patients in the IRV group had noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1.
Intervention Type
Other
Intervention Name(s)
Inspiratory-to-expiratory (I : E) ratio of 1:2
Intervention Description
After preoxygenation and induction of anesthesia, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2 for 5 min before endotracheal intubation.
Intervention Type
Other
Intervention Name(s)
Inspiratory-to-expiratory (I : E) ratio of 2:1
Intervention Description
After preoxygenation and induction of anesthesian, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1 for 5 min before endotracheal intubation.
Primary Outcome Measure Information:
Title
Safe Apnea Time
Description
The safe apnea time was defined as that period of time during which the arterial saturation as measured by pulse oximetry remained at or above 93% .
Time Frame
The arterial saturation as measured by pulse oximetry remained at or above 93% after endotracheal intubation immediately.
Secondary Outcome Measure Information:
Title
EtO2
Description
Fractional concentration of oxygen in end-tidal gas
Time Frame
After 3 minutes of preoxygenation After 5 minutes of noninvasive positive pressure ventilation
Title
EtO2
Description
Fractional concentration of oxygen in end-tidal gas
Time Frame
After 3 minutes of noninvasive positive pressure ventilation
Title
EtO2
Description
Fractional concentration of oxygen in end-tidal gas
Time Frame
After 5 minutes of noninvasive positive pressure ventilation
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:
Obese patients, aged 18-65 years, of either gender, ASA grade II-III, body mass index (BMI) > 30 kg / m2, scheduled for general anesthesia under tracheal intubation, signed informed consent.
Exclusion Criteria:
Patients who need rapid sequence induction (RSI); patients with expected difficult airway; severe chronic respiratory diseases, such as tuberculosis, bronchitis, bronchial asthma and COPD; patients with severe cardiovascular diseases, such as severe ischemic heart disease and pulmonary hypertension; patients with severe cerebrovascular diseases, such as cerebral hemorrhage and cerebral infarction; patients with abnormal basal metabolic rate, such as pregnancy, thyrotoxicosis, pheochromocytoma; and severe stomach reflux disease; patients with abnormal hemoglobin and hematocrit.
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
General Hospital Of Ningxia Medical University
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Inverse Ratio Ventilation During Induction of General Anesthesia on Safe Apnea Time in Obese Patients
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