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The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients

Primary Purpose

Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IE ratio 1:1
IE ratio 1:2
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-II adult patients scheduled for spine surgery under general anesthesia.
  • patient age : greater than 20 years and less than 65years
  • Body Mass Index(BMI) >25 kg/m2

Exclusion Criteria:

  • Patients who have severe pulmonary disease:

history of chronic obstructive pulmonary disease (COPD), asthma, or pneumothorax. Patients with haemodynamic instability, hypovolaemia, bronchopleural fistula, history of cardiopulmonary disease, or previous lung surgery are excluded.

Sites / Locations

  • Kyung Cheon Lee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IE ratio 1:1

IE ratio 1:2

Arm Description

Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.

Outcomes

Primary Outcome Measures

PaO2(Partial Pressure of Oxygen in Arterial Blood)
ten minutes after tracheal intubation to 90 min after prone position

Secondary Outcome Measures

Full Information

First Posted
November 9, 2016
Last Updated
October 28, 2019
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02961920
Brief Title
The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients
Official Title
The Influence of Prolonged Inspiratory Time on Respiratory Mechanics and Oxygenation in Obese Patients Undergoing Spine Surgery in the Prone Position
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The area of aesthesia-induced atelectasis is much larger in the obese compared with the non-obese, but there may also be more airway closure and impaired matching of ventilation and lung blood flow. When an anesthetized patient is turned to the prone position, dynamic compliance (Cdyn) decreases and peak airway pressure increases unless the abdomen hangs freely to prevent the abdominal viscera from compromising the diaphragm movement. Although the Wilson frame is designed to allow the abdomen to hang, it partially compresses the anterior abdominal wall and therefore does not allow the abdomen to hang completely, especially in obese patients. This in turn increases peak airway pressure and decreases Cdyn, oxygenation. This study aimed to investigate the effects of a prolonged I:E ratio (i.e., 1:1) compared with the conventional I:E ratio of 1:2 on respiratory mechanics and hemodynamics during spine surgery in the prone position in obese patients. We hypothesized that, compared with an I:E ratio of 1:2, a ratio of 1:1 improve oxygenation without hemodynamic instability .
Detailed Description
After written informed consent was obtained from all patients, 50 adult patients were enrolled in the study. The patients met the following inclusion criteria: (1) body mass index (BMI, weight in kilograms divided by the square of height in metres) > 25 kg/m2; (2) American Society of Anesthesiology (ASA) physical status classification grade I or II (BMI by itself was not used as the basis for the ASA classification); (3) aged 20 - 65 years; and (4) scheduled for elective spine surgery in prone position. Exclusion Criteria: Patients who have severe pulmonary disease: history of chronic obstructive pulmonary disease (COPD), asthma, or pneumothorax. Patients with haemodynamic instability, hypovolaemia, bronchopleural fistula, The enrolled patients were randomly allocated according to a predetermined allocation sequence to receive an I:E ratio of either 1:1 (group 1:1) or 1:2 (group 1:2). The allocation sequence with no blocking was generated in an Internet website Standard monitoring techniques, including electrocardiography, pulse oximetry, and noninvasive arterial blood pressure measurement, are applied upon arrival at the operating room. Anesthesia was induced with intravenous propofol 1.5 mg_kg-1 and rocuronium 0.8 mg_kg-1 was administered intravenously. After tracheal intubation, volume-controlled ventilation was initiated with an I:E ratio of 1:2 or 1:1, no positive end-expiratory pressure, and a tidal volume of 10 mL per ideal body weight (kg). A respiratory rate was adjusted in order to end-tidal carbon dioxide (EtCO2) of 33 - 36 mmHg during surgery. Anesthesia was maintained with an end-tidal concentration of 2-2.5 vol% sevoflurane in 40% oxygen/air. The bispectral index score was monitored continuously in order to maintain an adequate anesthetic depth and was targeted at a range of 40-60 during surgery. Radial artery cannulation was conducted for monitoring continuous arterial blood pressure and blood sampling. Respiratory, hemodynamic, and arterial blood gas data were assessed and recorded at three time points: ten minutes after tracheal intubation in the supine position (T1), 30 min after prone positioning (T2), 90 min after prone positioning(T3). Respiratory data consisted of peak airway pressure, plateau airway pressure, mean airway pressure, static compliance, EtCO2, respiratory rate, and minute volume. Arterial pH, arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2), and lactate level were obtained from arterial blood gas analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IE ratio 1:1
Arm Type
Experimental
Arm Description
Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
Arm Title
IE ratio 1:2
Arm Type
Active Comparator
Arm Description
Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.
Intervention Type
Device
Intervention Name(s)
IE ratio 1:1
Other Intervention Name(s)
one and one
Intervention Description
Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
Intervention Type
Device
Intervention Name(s)
IE ratio 1:2
Other Intervention Name(s)
one and two
Intervention Description
Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.
Primary Outcome Measure Information:
Title
PaO2(Partial Pressure of Oxygen in Arterial Blood)
Description
ten minutes after tracheal intubation to 90 min after prone position
Time Frame
ten minutes after tracheal intubation to 90 min after prone position

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II adult patients scheduled for spine surgery under general anesthesia. patient age : greater than 20 years and less than 65years Body Mass Index(BMI) >25 kg/m2 Exclusion Criteria: Patients who have severe pulmonary disease: history of chronic obstructive pulmonary disease (COPD), asthma, or pneumothorax. Patients with haemodynamic instability, hypovolaemia, bronchopleural fistula, history of cardiopulmonary disease, or previous lung surgery are excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Cheon Lee, MD
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Kyung Cheon Lee
City
Incheon
ZIP/Postal Code
22241
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Prolonged Inspiratory Time on Pulmonary Mechanics in Obese Patients

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