Clinical trial NCT02687282: Mallampati Score Before and After Cesarean Delivery
Official title: Ramathibodi Hospital, Mahidol University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alteration of Modified Mallampati Score
Keywords: Modified Mallampati score
Cesarean delivery
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thai pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37 weeks giving written informed consent.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate Modified Mallampati score changes before and after cesarean delivery
timeFrame: up tp 2 days
measure: Evaluate thyromental distance changes before and after cesarean delivery
timeFrame: up tp 2 days
measure: Evaluate upper lip bite score changes before and after cesarean delivery
timeFrame: up to 2 days
measure: Evaluate neck circumference changes before and after cesarean delivery
timeFrame: up to 2 days
Secondary outcomes:
measure: Oxytocin dosage and Alteration of Modified mallampati score
timeFrame: up tp 2 days
measure: Intraoperative intravenous fluid and Alteration of Modified mallampati score
timeFrame: up tp 2 days
measure: Estimate blood loss and Alteration of Modified mallampati score
timeFrame: up tp 2 days
Other outcomes:
Locations:
Study officials:
References:
citation: Quinn AC, Milne D, Columb M, Gorton H, Knight M. Failed tracheal intubation in obstetric anaesthesia: 2 yr national case-control study in the UK. Br J Anaesth. 2013 Jan;110(1):74-80. doi: 10.1093/bja/aes320. Epub 2012 Sep 17.
citation: Hawkins JL, Chang J, Palmer SK, Gibbs CP, Callaghan WM. Anesthesia-related maternal mortality in the United States: 1979-2002. Obstet Gynecol. 2011 Jan;117(1):69-74. doi: 10.1097/AOG.0b013e31820093a9.
citation: Chang J, Streitman D. Physiologic adaptations to pregnancy. Neurol Clin. 2012 Aug;30(3):781-9. doi: 10.1016/j.ncl.2012.05.001. Epub 2012 Jun 30.
citation: Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.
citation: Randell T. Prediction of difficult intubation. Acta Anaesthesiol Scand. 1996 Sep;40(8 Pt 2):1016-23. doi: 10.1111/j.1399-6576.1996.tb05620.x.
citation: Rocke DA, Murray WB, Rout CC, Gouws E. Relative risk analysis of factors associated with difficult intubation in obstetric anesthesia. Anesthesiology. 1992 Jul;77(1):67-73. doi: 10.1097/00000542-199207000-00010.
citation: Aydas AD, Basaranoglu G, Ozdemir H, Dooply SL, Muhammedoglu N, Kucuk S, Saidoglu L. Airway changes in pregnant women before and after delivery. Ir J Med Sci. 2015 Jun;184(2):431-3. doi: 10.1007/s11845-014-1138-8. Epub 2014 May 24.
citation: Bhavani-Shankar K, Lynch EP, Datta S. Airway changes during Cesarean hysterectomy. Can J Anaesth. 2000 Apr;47(4):338-41. doi: 10.1007/BF03020949.
citation: Boutonnet M, Faitot V, Katz A, Salomon L, Keita H. Mallampati class changes during pregnancy, labour, and after delivery: can these be predicted? Br J Anaesth. 2010 Jan;104(1):67-70. doi: 10.1093/bja/aep356.
citation: Farcon EL, Kim MH, Marx GF. Changing Mallampati score during labour. Can J Anaesth. 1994 Jan;41(1):50-1. doi: 10.1007/BF03009661.
citation: Guru R, Carere MD, Diwan S, Morau EL, Saunders J, Shorten GD. Effect of epidural analgesia on change in Mallampati class during labour. Anaesthesia. 2013 Jul;68(7):765-9. doi: 10.1111/anae.12288. Epub 2013 May 24.
citation: Honarmand A, Safavi MR. Prediction of difficult laryngoscopy in obstetric patients scheduled for Caesarean delivery. Eur J Anaesthesiol. 2008 Sep;25(9):714-20. doi: 10.1017/S026502150800433X. Epub 2008 May 9.
citation: Hu J, Huang S, Tian F, Sun S, Li N, Xie Y. A comparison of upper airway parameters in postpartum patients: vaginal delivery vs. caesarean section. Int J Clin Exp Med. 2014 Dec 15;7(12):5491-7. eCollection 2014.
citation: Pilkington S, Carli F, Dakin MJ, Romney M, De Witt KA, Dore CJ, Cormack RS. Increase in Mallampati score during pregnancy. Br J Anaesth. 1995 Jun;74(6):638-42. doi: 10.1093/bja/74.6.638.
citation: Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
citation: Idehen HO, Amadasun FE, Ekwere IT. Comparison of intravenous colloid and colloid-crystalloid combination in hypotension prophylaxis during spinal anesthesia for cesarean section. Niger J Clin Pract. 2014 May-Jun;17(3):309-13. doi: 10.4103/1119-3077.130231.
citation: Baker P. Assessment before airway management. Anesthesiol Clin. 2015 Jun;33(2):257-78. doi: 10.1016/j.anclin.2015.02.001.
citation: Hashim K, Thomas M. Sensitivity of palm print sign in prediction of difficult laryngoscopy in diabetes: A comparison with other airway indices. Indian J Anaesth. 2014 May;58(3):298-302. doi: 10.4103/0019-5049.135042.