Effects of Recruitment Maneuver During Intraoperative Period

Laparoscopic Hysterectomy Clinical Trial

Official title:

Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239547
• Other study ID #: osagir-4
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: November 2020
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy

Intervention

Procedure:
• Alveolar Recruitment maneuver (ARM) +PEEP
Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP
• PEEP
Following anesthesia induction and intubation, only 5 mmHg PEEP

Locations

Country	Name	City	State
Turkey	Balikesir University	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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