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Alteration of Modified Mallampati ScoreMSBACNCT02687282

Mallampati Score Before and After Cesarean Delivery

An observational study of Alteration of Modified Mallampati Score, run by Ramathibodi Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Alteration of Modified Mallampati Score
What is being tested?
Evaluate upper airway changes
How many people
104 participants
Where
No sites listed yet
Study dates
1 Feb 2016to 1 Sep 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Thai pregnant women scheduled for cesarean section, age ≥ 18 y at gestational age ≥ 37 weeks giving written informed consent.

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Ramathibodi Hospital, Mahidol University

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

Read the 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).

Being tested
Evaluate upper airway changes
Keywords
Modified Mallampati score, Cesarean delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluate upper airway changesOther

    Evaluate upper airway changes at several point of time before and after cesarean delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate Modified Mallampati score changes before and after cesarean delivery

    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)

    Measured: up tp 2 days

  2. Evaluate thyromental distance changes before and after cesarean delivery

    thyromental distance (centimeter) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)

    Measured: up tp 2 days

  3. Evaluate upper lip bite score changes before and after cesarean delivery

    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)

    Measured: up to 2 days

  4. Evaluate neck circumference changes before and after cesarean delivery

    Neck circumference (centimeter) before delivery, 2 and 6 hours after delivery, and post-operative day1 (the day of surgery and post-operative day 1)

    Measured: up to 2 days

Secondary outcomes (3)

  1. Oxytocin dosage and Alteration of Modified mallampati score

    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 )

    Measured: up tp 2 days

  2. Intraoperative intravenous fluid and Alteration of Modified mallampati score

    Evaluate the percentage of patients whose mallampati score increase from baseline between patient who recieved intravenous fluid ≥ 2000 ml and < 2000 ml

    Measured: up tp 2 days

  3. Estimate blood loss and Alteration of Modified mallampati score

    Evaluate the percentage of patients whose mallampati score increase from baseline between patient whose estimate blood loss≥ 1000 ml and < 1000 ml

    Measured: up tp 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2016 (estimated)
  2. Study start1 Feb 2016
  3. Primary completion15 Aug 2016
  4. Study completion1 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02687282
Sponsor's protocol ID
Ramaanes2559
Acronym
MSBAC
Status last verified
May 2017
First submitted
27 Jan 2016
Last updated
16 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22986421

  • 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.

    PubMed 21173646

  • 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.

    PubMed 22840789

  • 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.

    PubMed 18292672

  • 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.

    PubMed 8908216

  • 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.

    PubMed 1610011

  • 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.

    PubMed 24859287

  • 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.

    PubMed 10764179

  • 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.

    PubMed 20007793

  • Farcon EL, Kim MH, Marx GF. Changing Mallampati score during labour. Can J Anaesth. 1994 Jan;41(1):50-1. doi: 10.1007/BF03009661.

    PubMed 8111943

  • 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.

    PubMed 23710682

  • 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.

    PubMed 18471331

  • 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.

    PubMed 25664060

  • 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.

    PubMed 7640115

  • 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.

    PubMed 25501602

Questions about this trial

What is this clinical trial studying?

An observational study of Alteration of Modified Mallampati Score, run by Ramathibodi Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Modified Mallampati score changes before and after cesarean delivery (time frame: up tp 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02687282, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.

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