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

The Influence of Prolonged Inspiratory Time on Respiratory Mechanics and Oxygenation in Obese Patients Undergoing Spine Surgery in the Prone Position

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02961920
Enrollment
50
Registered
2016-11-11
Start date
2016-11-30
Completion date
2019-05-31
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

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.

Interventions

DEVICEIE ratio 1:2

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

DEVICEIE ratio 1:1

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

Sponsors

Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

South Korea

Participant flow

Recruitment details

Between November 2016 and October 2018, 50 patients who underwent lumbar spine surgery in our institution were assessed. Two patients dropped out. Thus, 48 patients achieved study protocol.

Participants by arm

ArmCount
IE Ratio 1:1
Set an I(inspiration):E(expiration) ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients. IE ratio 1:1: Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
24
IE Ratio 1:2
Set an I(inspiration):E(expiration) ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients. IE ratio 1:2: Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.
24
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studydid not achive stydy protocol schedule11

Baseline characteristics

CharacteristicIE Ratio 1:1IE Ratio 1:2Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
24 Participants24 Participants48 Participants
Age, Continuous52.3 years
STANDARD_DEVIATION 10
54.6 years
STANDARD_DEVIATION 13
53.42 years
STANDARD_DEVIATION 9.89
body mass index27.4 kg/m^2
STANDARD_DEVIATION 7.9
28.7 kg/m^2
STANDARD_DEVIATION 2.7
28.13 kg/m^2
STANDARD_DEVIATION 2.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
24 Participants24 Participants48 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Korea
24 participants24 participants48 participants
Sex: Female, Male
Female
6 Participants11 Participants17 Participants
Sex: Female, Male
Male
18 Participants13 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 24
other
Total, other adverse events
0 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 24

Outcome results

Primary

PaO2(Partial Pressure of Oxygen in Arterial Blood)

ten minutes after tracheal intubation to 90 min after prone position

Time frame: ten minutes after tracheal intubation to 90 min after prone position

ArmMeasureGroupValue (MEAN)Dispersion
IE Ratio 1:2PaO2(Partial Pressure of Oxygen in Arterial Blood)paO2 30min178.71 mmHgStandard Deviation 36.43
IE Ratio 1:2PaO2(Partial Pressure of Oxygen in Arterial Blood)PaO2 90min185.25 mmHgStandard Deviation 26.54
IE Ratio 1:1PaO2(Partial Pressure of Oxygen in Arterial Blood)PaO2 90min202.54 mmHgStandard Deviation 17.627
IE Ratio 1:1PaO2(Partial Pressure of Oxygen in Arterial Blood)paO2 30min198.04 mmHgStandard Deviation 17.667

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026