Effects of Recruitment Maneuver During Intraoperative Period

Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Hysterectomy
• Intervention / Treatment: Procedure: Alveolar Recruitment maneuver (ARM) +PEEP; Procedure: PEEP

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balikesir, Turkey
    • Balikesir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Recruitment; Patients classified to receive recruitment maneuver + 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.	Procedure: Alveolar Recruitment maneuver (ARM) +PEEP; Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP
EXPERIMENTAL: Non-recruitment; Patients classified to receive only 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.	Procedure: PEEP; Following anesthesia induction and intubation, only 5 mmHg PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of change in airway compliance	the patients airway compliance will be monitorised as milliliter / centimeter of water (mL/cmH2O) continuously by the anesthesia machine and will be recorded intermittently.	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
measurement of change in Airway resistance	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.	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
measurement of change in partial oxygen pressure (PaO2)	Arterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.	T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Balikesir University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: recruitment; pulmonary complication; oxygenisation
• Other Study ID Numbers: osagir-4

Drug and device information, study documents

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