Atelectasis Clinical Trial
Official title:
Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver
Verified date | March 2024 |
Source | National and Kapodistrian University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | March 5, 2024 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 pulmonle |
Country | Name | City | State |
---|---|---|---|
Greece | General Hospital of Athens "Alexandra" | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
Panagiota Griva |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta (?) Compliance (T1 -T7) | The compliance difference between T1 and T7, where T1 denotes the time of induction to anaesthesia and T7 is the release of pneumoperitoneum time. | intraoperative, after anesthesia induction and after the release of pneumoperitoneum | |
Primary | Delta (?) Compliance (T1 -T8) | The compliance difference between T1 and T8, where T8 is the time of the recruitment maneuver. | intraoperative, after anesthesia induction and after the recruitment maneuver | |
Primary | Delta (?) Compliance (T7 -T8) | The different compliance between T7 and T8 | intraoperative, after the release of pneumoperitoneum and after the recruitment maneuver | |
Secondary | Compliance (in mL/cmH2O) | Compliance of the lungs measured at the following time frames: after anesthesia induction (T1), after dorsal lithotomy position (T2), after Trendelenburg position (T3), 10 and 90 minutes after CO2 insufflation (T4, T5 respectively), after removal of Trendelenburg position (T6), after desufflation (T7), 10 minutes after an alveolar recruitment maneuver (T8). | intraoperative (T1-T8) | |
Secondary | Pplateau (in cmH2O) | end-inspiratory airway pressure measured at the following time frames: after anesthesia induction (T1), after dorsal lithotomy position (T2), after Trendelenburg position (T3), 10 and 90 minutes after CO2 insufflation (T4, T5 respectively), after removal of Trendelenburg position (T6), after desufflation (T7), 10 minutes after an alveolar recruitment maneuver (T8). | intraoperative (T1-T8) | |
Secondary | MAP (in mmHg) | Mean Arterial Pressure measured at the following time frames: after anesthesia induction (T1), after dorsal lithotomy position (T2), after Trendelenburg position (T3), 10 and 90 minutes after CO2 insufflation (T4, T5 respectively), after removal of Trendelenburg position (T6), after desufflation (T7), 10 minutes after an alveolar recruitment maneuver (T8). | intraoperative (T1-T8) | |
Secondary | Intraoperative administration of vasoactive agents | The dose of the vasoactive agents administrated to maintain a Mean Arterial Pressure > 65mmHg during the alveolar recruitment maneuver | intraoperative, after alveolar recruitment maneuver |
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