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Clinical Trials/NCT07299396
NCT07299396
Completed
Not Applicable

THE EFFECT OF ALVEOLAR RECRUITMENT MANOEUVRE ON INTRAOPERATIVE HAEMODYNAMICS

Balikesir University1 site in 1 country70 target enrollmentStarted: January 9, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Balikesir University
Enrollment
70
Locations
1
Primary Endpoint
Effect of RM on heart rate (in bpm)

Overview

Brief Summary

Alveolar recruitment manoeuvre plays a key role in the prevention of atelectasis. In addition, it affects haemodynamic parameters. This study aims to investigate the effects of RM on haemodynamic parameters using minimally invasive monitoring techniques.

Detailed Description

During laparoscopic hysterectomy, pneumoperitoneum is created with carbon dioxide (CO₂) to provide surgical field of view and the patient is placed in Trendelenburg position. This increases intrathoracic pressure, decreases lung compliance and increases the risk of atelectasis. Therefore, lung protective ventilation strategies such as alveolar recruitment manoeuvre (RM), individualised PEEP application and low tidal volume are recommended. RM aims to increase lung compliance and prevent atelectasis by reopening collapsed alveoli. However, changes in haemodynamic parameters, especially mean arterial pressure and cardiac output, may occur during RM. In addition to standard monitoring for the management of these changes, haemodynamic evaluation can be performed with minimally invasive methods such as arterial waveform analysis. In this study, we aimed to evaluate the effects of RM applied during laparoscopic hysterectomy on intraoperative haemodynamic parameters using arterial waveform analysis.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ASA Class 1-2 patients 18-70 years old

Exclusion Criteria

  • \<18 y, BMI\>40
  • Patients receiving invasive mechanical ventilator support in the last 1 month
  • Patients who have received chemotherapy or radiotherapy in the last 2 months
  • Those with severe lung disease (COPD, asthma, pulmonary infection, bronchiectasis, previous need for non-invasive mechanical ventilation, oxygen therapy or steroid therapy for acute attack)
  • Known severe pulmonary hypertension
  • Patient refusal to participate in the study
  • Intracranial tumour
  • Haemodynamic instability
  • Neuromuscular disease
  • Pathologies causing increased intracranial and intraocular pressure

Outcomes

Primary Outcomes

Effect of RM on heart rate (in bpm)

Time Frame: perioperatively

measurement of heart rate in bpm

Effect of RM on pressure mmHg

Time Frame: perioperatively

blood pressure measurement in mmmercury

Effect of RM on Cardiac index(CI)

Time Frame: intraoperatively

Cardiac Index measurement via an arterial cannula as l/min/m2

Effect of RM on stroke volume index(SVI)

Time Frame: intraoperatively

SVI measurement via arterial cannula as L/min/m2

Effect of RM on pulse pressure variablity(PPV)

Time Frame: intraoperatively

pulse pressure variability measured by finger probe as cm/s

Effect of RM on systemic vascular resistance index(SVRI)

Time Frame: intraoperatively

systemic vascular resistance index(SVRI) measurement via arterial cannula as L/min/m2

Effect of RM on cardiac power index(CPI)

Time Frame: intraoperatively

cardiac power index(CPI) measurement via arterial line as ml/min/m2

Secondary Outcomes

  • Effect of RM on Compliance(intraoperatively)
  • Effect of RM on Oxygenation(İntraoperatively)
  • Postoperative pulmonary comlications (infection, bronchospasm, pleural effusion, atelectasis, respiratory failure)(postoperative day 1 and 3)

Investigators

Sponsor
Balikesir University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ozlem Sagir, MD

Professor, MD

Balikesir University

Study Sites (1)

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