A prospective study to compare effects of laparoscopic surgery on haemodynamic and respiratory parameters using two different techniques of airway management in children

Completed

• Conditions: ASA GRADE I

• Registration Number: CTRI/2018/02/011697
• Lead Sponsor: Vardhaman Mahavir Medical College and Safderjung Hospital

Brief Summary

**Aims and Objectives:** Tostudy the effect of pneumoperitoneum on hemodynamic and respiratory parametersusing Proseal LMA and endotracheal intubation and compare risk and benefits of usingthese two devices for video-endoscopic surgeries in children.

**Method:** Total 60 ASA grade I childrenof either sex in the age group of 1-10 years were assigned randomlyinto two groups of 30 patients in each. Group I - Consists of patients airway secured with Proseal LMAand GroupII - Consists of patients airway secured with endotracheal tube. Haemodynamic parameterssuch as HR, SBP, DBP, MBP, ECG and various respiratory parameters such as SpO2,EtCO2, PIP and PP were recorded during the study period.

**Results:** We foundthat HR, SBP, DBP, MAP increased significantly following ETT intubation ascompared to response after PLMA insertion. There were similar changes observedin haemodynamic parameters during and after insufflation period in both thegroup. No significant changes observed in SpO2 throughout study but EtCO2,PIP, PP showed significant changes after insufflation and 5 min afterdesufflation in both the groups. There intergroup comparisons were analogous;however return of EtCO2 towards baseline was quite delayed in ETT as comparedwith PLMA. PIP and PP return towards normal was earlier in ETT group than PLMAgroup.

**Conclusion:**Both PLMA and ETT can be safely used, PLMA can be a better choice as it doesn’tevoke any intubation response, return of EtCO2 earlier towardsbaseline than ETT and not showed any added complication to ETT intubation.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-14
• Study Completion: 2014-02-14
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All patients in study were of American Society Of Anesthesiology (ASA) Grade I in the age group of 1-10 years of either sex posted for video-endoscopic surgery.

Exclusion Criteria

• Patients with known cardiovascular, respiratory or neurological diseases.
• Patients having upper respiratory tract infection.
• Patients with coagulation disorders.
• Patients subsequently converted to open surgical procedure in intraoperative period.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Both Proseal LMA and Endotracheal tube can be safely used, proseal being better choice.	5 min before insertion of an airway device : t0 | 5 min after insertion of an airway device : t1 | 5 min before insufflation of CO2 : t2 | 15 min after insufflation of CO2 : t3 | 30 min after insufflation of CO2 : t4 | 5 min after desufflation of CO2 : t5 | 5 min after removal of airway device : t6.

Secondary Outcome Measures

Name	Time	Method
Multi-centric studies with much larger sample of subjects and ethnicity are needed for validation of the concluded results.	NIL

Trial Locations

Locations (1)

VMMC AND SAFDARJANG HOSPITAL; 🇮🇳 Delhi, DELHI, India

VMMC AND SAFDARJANG HOSPITAL

🇮🇳Delhi, DELHI, India

AMIT WANKHEDE

Principal investigator

9582414799

amit22gmcnagpur@gmail.com