Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203665
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-12-06
Brief Title:
Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver
Sponsor:
Panagiota Griva
Organization:
National and Kapodistrian University of Athens
Study Overview
Official Title:
Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the hypothesis that an alveolar recruitment maneuver after the release of pneumoperitoneum would restore the lung compliance to the baseline values after a laparoscopic gynaecologic surgery
Detailed Description:
In recent years laparoscopic surgery is a common minimal invasive technique which ensures the avoidance of prolong hospital stay long duration surgery postoperative pain operation scars However laparoscopic surgery has a negative impact on respiratory mechanics because of the pneumoperitoneum the changes in position and the appliance of positive pressure ventilation The increase in abdominal pressure as a result of carbon dioxide insufflation and the typical head-down body position have been shown to impair respiratory function Application of a pneumoperitoneum-induced elevation of intraabdominal pressure elevates the diaphragm and results in a compression of the dependent ventral lung regions As a consequence the amount of atelectasis is increased The insufflation of CO2 reduced respiratory system compliance and increased peak inspiratory and mean airway pressures Additionally changes to the lithotomy and Trendelenburg position during gynaecologic surgery reduce lung compliance by altering the location of intestinal contents and diaphragm Especially the Trendelenburg position potentiates the effects of abdominal pressure via gravity and relaxation of the diaphragm thereby increasing the airway pressure and reducing the functional residual capacity which results in further changes in the respiratory system Therefore we evaluated the effect of an alveolar recruitment maneuver during gynaecologic laparoscopic surgery by determining the changes in lung compliance
Design Prospective study Setting Operating room of a hospital Patients 31 ASA physical status I and II patients scheduled to undergo gynaecologic laparoscopic surgery in the dorsal lithotomy position
Interventions The surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation Vt 6 ml Kg ideal body weight RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP 6- 8 cm H20 An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum
Measurements Respiratory mechanics including dynamic compliance were measured continuously Respiratory measures were recorded together with arterial blood gases after induction T1 with the patient placed in the dorsal lithotomy position T2 10 and 90 minutes after CO2 insufflation T3 and T4 immediately after desufflation in the lithotomy and supine positions T5 and T6 and 10 minutes after a pulmonary recruitment maneuver at the conclusion of surgery T7
Inclusion criteria
18 years old patients
A gynaecologic laparoscopic surgery would be performed
Duration of the surgery over 90 minutes
Exclusion criteria
Chronic Obstructive Lung Disease with FEV1 60 of predicted value
Lung Emphysema
BMI 30
Hemodynamic instability during the operation
Acute cor pulmonale
Design Prospective study Setting Operating room of a hospital Patients 31 ASA physical status I and II patients scheduled to undergo gynaecologic laparoscopic surgery in the dorsal lithotomy position
Interventions The surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation Vt 6 ml Kg ideal body weight RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP 6- 8 cm H20 An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum
Measurements Respiratory mechanics including dynamic compliance were measured continuously Respiratory measures were recorded together with arterial blood gases after induction T1 with the patient placed in the dorsal lithotomy position T2 10 and 90 minutes after CO2 insufflation T3 and T4 immediately after desufflation in the lithotomy and supine positions T5 and T6 and 10 minutes after a pulmonary recruitment maneuver at the conclusion of surgery T7
Inclusion criteria
18 years old patients
A gynaecologic laparoscopic surgery would be performed
Duration of the surgery over 90 minutes
Exclusion criteria
Chronic Obstructive Lung Disease with FEV1 60 of predicted value
Lung Emphysema
BMI 30
Hemodynamic instability during the operation
Acute cor pulmonale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None