Effects of Recruitment Maneuver During Intraoperative Period

Not Applicable

Completed

• Conditions: Laparoscopic Hysterectomy
• Interventions: Procedure: PEEP; Procedure: Alveolar Recruitment maneuver (ARM) +PEEP

• Registration Number: NCT04239547
• Lead Sponsor: Balikesir University

Brief Summary

The aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy.

Detailed Description

In patients over 18 years who are scheduled for laparoscopic hysterectomy volunteering to participate in our study will receive anesthesia induction with one of our standard general anesthesia protocols. After intubation recruitment maneuver will be applied to the study group. General anesthesia and mechanical ventilation will be continued and completed according to our standard practice without any further intervention. Throughout the intraoperative period respiratory and haemodynamic parameters including compliance, airway resistance, mean arterial pressure, heart rate, pulse oxymetry, blood gas analysis, the applied inhalational anesthetic agent, minimum alveolar concentration, expiratory agent concentration and total agent consumption will be recorded. At the end of the operation anesthesia will be terminated and patients will be transferred to postanesthesia care unit (recovery unit after recovery and further discharged from to the ward when their Aldrete score is \>8. The patients will be examined for respiratory complications on postoperative day 1, and will be followed up by telephone on day 5.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-27
• Primary Completion: 2020-05-01
• Study Completion: 2020-08-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• American Society of Anesthesiology (ASA) I-II
• > 18 y
• laparoscopic hysterectomy patients

Exclusion Criteria

• Patient refusal to participate in the study
• <18 y, BMI> 40
• Patients receiving invasive MV support in the last 1 month
• Patients who received chemotherapy or radiotherapy in the last 2 months
• Patients with severe pulmonary disease (COPD, asthma, pulm infection, bronchiectasis) (those who have previously received Non-Invasive MV, oxygen therapy or steroid therapy for an acute attack)
• Those with known severe pulmonary Hypertension
• Intracranial tm
• Hemodynamic instability
• Shock.
• Neuromuscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-recruitment	PEEP	Patients classified to receive only 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.
Recruitment	Alveolar Recruitment maneuver (ARM) +PEEP	Patients classified to receive recruitment maneuver + 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.

Primary Outcome Measures

Name	Time	Method
measurement of change in Airway resistance	T1:1 minute after intubationT2:5 min after MV T3:5 minute after pneumoperitoneum T4:3 minute after Trendelenburg position (TP) T5:10 minutes after TP T6:20 minutes after TP T7:10 minutes after pneumoperitoneum deflation T8:1 minute before extubation	the patients airway compliance will be monitorised as centimeter of water/ liter/ minute (cmH2O/L/min) continuously by the anesthesia machine and will be recorded intermittently.
measurement of change in partial oxygen pressure (PaO2)	T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation	Arterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.
measurement of change in airway compliance	T1:1minute(min)after intubationT2:5 min after Mechanical Ventilation(MV),T3:5 min after pneumoperitoneum,T4:3 min after Trendelenburg position(TP),T5:10 min after TP T6:20 min after TP T7:10 min after pneumoperitoneum deflation T8:1 min before extubation	the patients airway compliance will be monitorised as milliliter / centimeter of water (mL/cmH2O) continuously by the anesthesia machine and will be recorded intermittently.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Postoperative respiratory distress, cough, phlegm	T9: 24 hours after surgery . T10: on postoperative day 5	Pulmonary complications including respiratory distress, cough, phlegm will be evaluated by questionnaire and recorded.

Trial Locations

Locations (1)

Balikesir University; 🇹🇷 Balikesir, Turkey