Mallampati Score Before and After Cesarean Delivery

Completed

• Conditions: Alteration of Modified Mallampati Score

• Registration Number: NCT02687282
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

Mallampati class change has not been well evaluated during the cesarean delivery. Various factors regarding to cesarean delivery might influence this changes. The aim of this study was to evaluate the Mallampati class before and after cesarean delivery and to identify predictive factors of the changes..

Study Type: Observational Cross-sectional study

Detailed Description

Mallampati class, thyromental distance, neck circumference, and upper lip bite test were evaluated at four time intervals : during pre-anesthetic visit (T0), 1-hour (T1), 6-hour (T2), and 24-hour after delivery (T3).

Study Timeline

• Study First Submitted: 2016-01-27
• Study Start: 2016-02-01
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-22
• Primary Completion: 2016-08-15
• Study Completion: 2016-09-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

Inclusion Criteria

• Pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37 weeks giving written informed consent.
• Initial Mallampati score ≤ III
• Normal clinical course

Exclusion Criteria

• Patient who denied to participate the study
• Initial Mallampati score ≥ IV
• Age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate upper lip bite score changes before and after cesarean delivery	up to 2 days	Upper lip bite score (score 1-4; 1 = easy airway and 4 = difficult airway) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
Evaluate Modified Mallampati score changes before and after cesarean delivery	up tp 2 days	Modified Mallampati score (score 1-4;1= easy airway and 4 = difficult airway) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
Evaluate thyromental distance changes before and after cesarean delivery	up tp 2 days	thyromental distance (centimeter) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)
Evaluate neck circumference changes before and after cesarean delivery	up to 2 days	Neck circumference (centimeter) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)

Secondary Outcome Measures

Name	Time	Method
Oxytocin dosage and Alteration of Modified mallampati score	up tp 2 days	Evaluate the percentage of patients whose mallampati score increase from baseline between patient who recieved high dose oxytocin (≥ 0.6 U/minl) and low dose oxytocin ( \<0.6 U/min )
Intraoperative intravenous fluid and Alteration of Modified mallampati score	up tp 2 days	Evaluate the percentage of patients whose mallampati score increase from baseline between patient who recieved intravenous fluid ≥ 2000 ml and \< 2000 ml
Estimate blood loss and Alteration of Modified mallampati score	up tp 2 days	Evaluate the percentage of patients whose mallampati score increase from baseline between patient whose estimate blood loss≥ 1000 ml and \< 1000 ml