An interventional study of Recruitment Maneuver in Atelectasis and Compliance, Patient, sponsored by Panagiota Griva. Completed at 1 site in Greece. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Panagiota Griva · Not applicable, Interventional, and Diagnostic
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.
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:
Exclusion criteria:
301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.
This study's enrollment of 31 is below the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.
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Exclusion Criteria:
An alveolar recruitment nameuver will be performed after the release of pneumoperitoneum
Diagnostic Test: Recruitment Maneuver
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.
Delta (Δ) 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.
Time frame: intraoperative, after anesthesia induction and after the release of pneumoperitoneum
Delta (Δ) Compliance (T1 -T8)
The compliance difference between T1 and T8, where T8 is the time of the recruitment maneuver.
Time frame: intraoperative, after anesthesia induction and after the recruitment maneuver
Delta (Δ) Compliance (T7 -T8)
The different compliance between T7 and T8
Time frame: intraoperative, after the release of pneumoperitoneum and after the recruitment maneuver
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).
Time frame: intraoperative (T1-T8)
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).
Time frame: intraoperative (T1-T8)
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).
Time frame: intraoperative (T1-T8)
Intraoperative administration of vasoactive agents
The dose of the vasoactive agents administrated to maintain a Mean Arterial Pressure \> 65mmHg during the alveolar recruitment maneuver
Time frame: intraoperative, after alveolar recruitment maneuver
Plan to share: No
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