Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver

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.

Study Overview

• Status: Completed
• Conditions: Compliance, Patient; Atelectasis
• Intervention / Treatment: Diagnostic test: Recruitment Maneuver

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11528
      • General Hospital of Athens "Alexandra"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients enrolled in the protocol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	intraoperative, after anesthesia induction and after the recruitment maneuver
Delta (Δ) Compliance (T7 -T8)	The different compliance between T7 and T8	intraoperative, after the release of pneumoperitoneum and after the recruitment maneuver

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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

Collaborators and Investigators

• Sponsor: Panagiota Griva

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): March 5, 2024

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 275/27-04-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No