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

NCT06203665 | Completed

• 1 other identifier: 275/27-04-2023
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis; Compliance, Patient

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Compliance (in mL/cmH2O)

  intraoperative (T1-T8)

• Pplateau (in cmH2O)

  intraoperative (T1-T8)

• MAP (in mmHg)

  intraoperative (T1-T8)

• Intraoperative administration of vasoactive agents

  intraoperative, after alveolar recruitment maneuver

Study Arms (1)

Patients enrolled in the protocol

EXPERIMENTAL

An alveolar recruitment nameuver will be performed after the release of pneumoperitoneum

Diagnostic Test: Recruitment Maneuver

Interventions

Recruitment Maneuver DIAGNOSTIC_TEST

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.

Patients enrolled in the protocol

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old patients
• A gynaecologic laparoscopic surgery would be performed
• Duration of the surgery over 90 minutes

You may not qualify if:

• Chronic Obstructive Lung Disease with FEV1 \< 60 of predicted value
• Lung Emphysema
• BMI \> 30
• Hemodynamic instability during the operation
• Acute cor pulmonle

Sponsors & Collaborators

• Panagiota Griva: lead

Study Sites (1)

General Hospital of Athens "Alexandra"

Athens, Attica, 11528, Greece

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Patient Compliance

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 12, 2024
• Study Start: June 7, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 5, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)